## Protocol Section
### Identification Module
**NCT ID:** NCT02043379

**Brief Title:** Post-bypass Prophylactic IVIG in Infants and Neonates

**Official Title:** Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates

#### Organization Study ID Info
**ID:** F13114002
#### Organization
**Class:** OTHER
**Full Name:** University of Alabama at Birmingham
#### Secondary ID Infos
**Domain:** UAB Institutional Reveiw Board
**ID:** F13114002
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-13

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-04-13

**Type:** ACTUAL

**Results First Submit Date:** 2016-10-14

**Results First Submit QC Date:** 2017-03-01

#### Start Date
**Date:** 2014-05

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2014-01-23
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-14
**Study First Submit QC Date:** 2014-01-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Grifols Biologicals, LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alabama at Birmingham

#### Responsible Party

**Investigator Affiliation:** University of Alabama at Birmingham

**Investigator Full Name:** Jeffrey Alten, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).

**Detailed Description:** The intense post-CPB systemic inflammatory response syndrome (SIRS) is well described in neonates and infants. Increased production and release of pro-inflammatory cytokines, including Tumor Necrosis Factor, Interleukin1-B, and Interleukin-6 may suppress myocardial contractility, induce capillary leak, and activate complement and the clotting cascade - together leading to potential organ injury and death. SIRS is also frequently accompanied by impairment of the humoral immune response. One potential reason for this acquired immunodeficiency after cardiac surgery is the removal of immunoglobulins (Ig)s from the vascular space into other compartments where they are either sequestered or lost from the body altogether. We recently demonstrated that such Ig depletion from the intravascular compartment occurs in neonates following cardiac surgery. In a retrospective study of 53 children \<3 months of age, we showed that plasma Immunoglobulin G (IgG) concentration drops precipitously after cardiac surgery and does not return to preoperative levels by 7 days; 51% of patients had hypogammaglobulinemia.

An important question is whether post-CPB low IgG has clinical consequence. IgG plays an essential role in the humoral immune system, activating complement and inducing the phagocytic system to neutralize pathogens. IgG deficiency is a known risk factor for infections in other pediatric populations. We were the first to demonstrate that post-CPB hypogammaglobulinemia is associated with worse clinical outcomes, including increased secondary infections (37% vs.12% in those without low IgG, p\<0.05). These novel findings are paramount in that they identify a potential modifiable risk factor to improve outcomes after pediatric cardiac surgery with CPB. Additionally, low IgG is accompanied by fluid overload and prolonged mechanical ventilation. Igs constitute an important component of plasma oncotic pressure, so hypogammaglobulinemia may exacerbate anasarca, prolonging postoperative convalescence and increasing the morbidities associated with increased ICU length of stay.9

Igs have an increasingly recognized role in modulating the innate immune response. Present use of IVIG exceeds mere antibody replacement and extends to the treatment of autoimmune and inflammatory conditions. In fact, more than 75% of IVIG use in the U.S. today is for the treatment of inflammatory conditions, where proposed mechanisms include reduction of pro-inflammatory cytokine and adhesion molecule expression, superantigen neutralization, restoration of glucocorticoid responsiveness, and blockade of complement fragment deposition. It is plausible that IVIG could benefit neonates after cardiac surgery not only via restoration of humoral opsonization capacity, but also as a modulator of innate immunity and SIRS. According to this model, tissue injury, CPB, and shock trigger SIRS, leading to hypogammaglobulinemia and resultant increased susceptibility to inflammatory dysregulation which might be ameliorated via administration of IVIG.

In an adult study, IVIG failed to benefit postoperative cardiac patients with severe SIRS. However, the dose of IVIG given was relatively small compared with that typically given for autoimmune and inflammatory conditions. Neonates and infants may be more susceptible to the harmful effects of acquired hypogammaglobulinemia than adults as they may be unable to generate adequate quantities of antibodies in response to pathogens, relying mainly on maternal Igs until around the 4th to 6th month of life. In addition, they display an exaggerated inflammatory response to CPB as compared with older children and adults, so they might stand to benefit more from IVIG as an immunomodulator.

Because of the increased vulnerability to acquired infection and other morbidities in the setting of hypogammaglobulinemia as result of enhanced SIRS and immune dysfunction, it is feasible that normalization of IgG concentration in the neonatal and infant population may improve clinical outcomes via restoration of the humoral immune system, modulation of the innate immune system, and restoration of intravascular oncotic pressure. The appropriate IgG level threshold for treatment and optimal plasma IgG level to target after administration of IVIG are presently unknown.

### Conditions Module

**Conditions:**

- Hypogammaglobulinemia

- Congenital Heart Disease

**Keywords:**

- congenital heart disease

- Cardiopulmonary Bypass

- Hypogammaglobulinemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose and will be administered per hospital standards for IVIG administration.

**Intervention Names:**

- Drug: IVIG

**Label:** IVIG

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug. This infusion will be administered as if the subject is receiving IVIG according to hospital policy.

**Intervention Names:**

- Other: Placebo

**Label:** Normal Saline

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IVIG

**Description:** Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.

**Name:** IVIG

**Other Names:**

- Gamunex

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Normal Saline

**Description:** If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.

**Name:** Placebo

**Other Names:**

- Normal Saline

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The primary endpoint of this study is incidence of post-operative infections through hospital discharge

**Measure:** Post-Operative Infections

**Time Frame:** until Hospital Discharge, an average of 30 days

**Description:** Any positive culture or treatment for culture negative sepsis within 1 week of surgery

**Measure:** Post-operative Infection

**Time Frame:** within 1 week of surgery

**Description:** Any positive blood culture during the post-operative period until hospital discharge

**Measure:** Blood Stream Infection

**Time Frame:** until Hospital Discharge, an average of 30 days

**Measure:** Blood Stream Infection Within 1 Week of Surgery

**Time Frame:** 7 days

#### Secondary Outcomes

**Description:** Plasma albumin will be assessed at 24 and 48 hours.

**Measure:** Post-operative Plasma Albumin

**Time Frame:** up to 48 hours post CPB

**Description:** The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.

**Measure:** Fluid Overload Variables

**Time Frame:** 0-24 hours post-CPB

**Description:** The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation.

**Measure:** Post-operative Inotrope Score

**Time Frame:** first 48 hours post-CPB

**Description:** Alive, ventilator free days will be recorded at hospital discharge.

**Measure:** Respiratory Variables

**Time Frame:** until Hospital Discharge, an average of 30 days

**Description:** From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.

**Measure:** Hospital Discharge

**Time Frame:** Approximately 1 month

**Description:** Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op

**Measure:** Plasma Immunoglobulins

**Time Frame:** 5 days post-op

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interferon-gamma Plasma Cytokine Levels

**Time Frame:** Pre-operative to 48 hours post-operative

**Description:** Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.

**Measure:** Immunoglobulin Concentration in Chest Tube Drainage

**Time Frame:** 24 hours post-op

**Description:** Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .

**Measure:** Mortality

**Time Frame:** Approximately 1 month

**Description:** The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.

**Measure:** Intensive Care Unit Length of Stay

**Time Frame:** 1 month

**Description:** The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.

**Measure:** Fluid Overload Variables

**Time Frame:** 0-48 hours post-CPB

**Description:** Time until first extubation in hours

**Measure:** Respiratory Variables

**Time Frame:** until extubation, an average of 2 days

**Description:** Total time duration of post-operative length of mechanical ventilation until hospital discharge

**Measure:** Respiratory Variables

**Time Frame:** until extubation, an average of 2 days

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interleukin-10 Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interleukin-12p70 Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interleukin-1b Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interleukin-6 Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Interleukin-8 Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.

**Measure:** Tumor Necrosis Factor Plasma Cytokine Levels

**Time Frame:** pre-operative through 48 hours post-operative

**Description:** Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.

**Measure:** Immunoglobulin Concentration in Peritoneal Dialysis Drainage

**Time Frame:** 24 hours post-op

**Description:** Pre-operative and 48 hour post-operative maximum creatinine recorded.

**Measure:** Serum Creatinine

**Time Frame:** 48 hours

**Measure:** Lactic Acid

**Time Frame:** pre-operative through 24 hours post-operative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Infants \<6 months old
* Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

* Requirement of extra corporeal membrane oxygenation in the operating room
* Known immune deficiency
* Current Do Not Resuscitate or limitation of care order
* Current enrollment in another interventional clinical study
* Refusal of parental consent

**Maximum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Children's of Alabama

**State:** Alabama

**Zip:** 35233

#### Overall Officials

**Official 1:**

**Affiliation:** University of Alabama at Birmingham Pediatric Cardiac Critical Care

**Name:** Jeffrey Alten, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** IPD will not be shared with other individuals

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: HIGH

- As Found: Congenital Heart Disease

- ID: M3711

- Name: Agammaglobulinemia

- Relevance: HIGH

- As Found: Hypogammaglobulinemia

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000000361

- Term: Agammaglobulinemia

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: HIGH

- As Found: Microliters

- ID: M8836

- Name: gamma-Globulins

- Relevance: LOW

- As Found: Unknown

- ID: M20191

- Name: Rho(D) Immune Globulin

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016756

- Term: Immunoglobulins, Intravenous

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** IVIG

**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.

**ID:** EG000

**Other Num at Risk:** 30

**Serious Number At Risk:** 30

**Title:** IVIG

**Group ID:** EG001

**Title:** Normal Saline

**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.

**ID:** EG001

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Normal Saline

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 30

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 50

**Units:** Participants

### Group

**ID:** BG000

**Title:** IVIG

**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.

### Group

**ID:** BG001

**Title:** Normal Saline

**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 30

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 6

**Upper Limit:** 50.75

**Value:** 9

#### Measurement

**Group ID:** BG001

**Lower Limit:** 6.25

**Upper Limit:** 79.5

**Value:** 47

#### Measurement

**Group ID:** BG002

**Lower Limit:** 6

**Upper Limit:** 74.75

**Value:** 11.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 3.17

**Upper Limit:** 3.99

**Value:** 3.45

#### Measurement

**Group ID:** BG001

**Lower Limit:** 3.04

**Upper Limit:** 4.52

**Value:** 3.85

#### Measurement

**Group ID:** BG002

**Lower Limit:** 3.13

**Upper Limit:** 4.09

**Value:** 3.51

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 37

**Upper Limit:** 39

**Value:** 38

#### Measurement

**Group ID:** BG001

**Lower Limit:** 37

**Upper Limit:** 39.75

**Value:** 38.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 37

**Upper Limit:** 39

**Value:** 38

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** 1

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 7

**Class Title:** 2

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 15

**Class Title:** 3

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 16

**Class Title:** 4

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** 5

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 73.5

**Upper Limit:** 120.3

**Value:** 105.5

#### Measurement

**Group ID:** BG001

**Lower Limit:** 68

**Upper Limit:** 122.3

**Value:** 91.5

#### Measurement

**Group ID:** BG002

**Lower Limit:** 70.5

**Upper Limit:** 120

**Value:** 97.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 42.5

**Upper Limit:** 70

**Value:** 52

#### Measurement

**Group ID:** BG001

**Lower Limit:** 44.5

**Upper Limit:** 78.5

**Value:** 56

#### Measurement

**Group ID:** BG002

**Lower Limit:** 44.5

**Upper Limit:** 70

**Value:** 53.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 10

**Class Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 15

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** No

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** days
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Weight
**Unit of Measure:** kilograms
### Measure 6
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Gestational Age
**Unit of Measure:** weeks
### Measure 7
**Description:** The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery) Congenital Heart Surgery Mortality Categories. The STAT Mortality Categories range from 1 to 5 with higher values indicating greater risk of mortality associated with operations for congenital heart disease
**Parameter Type:** NUMBER
**Title:** STAT category
**Unit of Measure:** participants
### Measure 8
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Cardiopulmonyar bypass time
**Unit of Measure:** minutes
### Measure 9
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Aortic cross clamp time
**Unit of Measure:** minutes
### Measure 10
**Description:** Subjects requiring mechanical ventilation in the pre-operative period for either respiratory or cardiac support.
**Parameter Type:** NUMBER
**Title:** Intubated Pre-operatively
**Unit of Measure:** subjects
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jalten@peds.uab.edu
**Organization:** UAB Pediatric Cardiac Critical Care Medicine
**Phone:** (205) 975-3123
**Title:** Jeffrey Alten, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 1
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 1
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.26
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-CPB albumin
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.42
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post CPB albumin
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.06
**P-Value Comment:** a p-value of \<0.05 represents the threshold for test signficance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.52
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Admit Inotrope Score
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.81
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hours post-operative inotrope score
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.82
**P-Value Comment:** a p value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hours post-operative inotrope score
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.9
**P-Value Comment:** a p value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hours post-operative inotrope score
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.23
**P-Value Comment:** a p-value of \<0.05 represents the threshold for statistical signficance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.49
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.79
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative IgG level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.32
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hours post-operative IgG level
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.36
**P-Value Comment:** a p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** post-operative day 3 (72 hours) IgG level
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** p-value of \<0.05 represents the threshold for statistical signficance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** post-operative day 5 (120 hours) IgG level
**Non-Inferiority Comment:** power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** <0.01
**P-Value Comment:** p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.60
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.06
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.06
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hours post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.33
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hours post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.05
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hours post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.83
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour levels
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.27
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.34
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 8 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.14
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.13
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.02
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 1
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.4
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0-48 hours post-CPB
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.09
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0-24 hours post CPB
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.52
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.72
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.63
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.41
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.34
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.47
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.42
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.82
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.44
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 19
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.28
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.37
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.42
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.31
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.4
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 20
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.1
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.12
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.51
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.27
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.88
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 21
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.35
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.39
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.58
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.36
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.61
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 22
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.1
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.02
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.34
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.35
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.67
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.47
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 23
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.46
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.04
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.14
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.82
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.9
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 48 hour post-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.78
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 24
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 0 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.37
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 4 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.47
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 8 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.47
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 12 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.79
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour level
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.04
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 25
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.43
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** max
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.68
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 26
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** pre-operative
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation.
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.87
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 24 hour post-operative max
**Non-Inferiority Comment:** Power calculations were not performed on this statistical calculation
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 0.79
**P-Value Comment:** A p-value of \<0.05 represents the threshold for statistical significance
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.74
- **Upper Limit:** 
- **Value:** 3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.67
- **Upper Limit:** 
- **Value:** 4.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.57
- **Upper Limit:** 
- **Value:** 3.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 3.6
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.6
- **Spread:** 
- **Upper Limit:** 74
- **Value:** 30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 34.4
- **Spread:** 
- **Upper Limit:** 87
- **Value:** 58.1
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.23
- **Spread:** 
- **Upper Limit:** 7.95
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.15
- **Spread:** 
- **Upper Limit:** 6.6
- **Value:** 4.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.25
- **Spread:** 
- **Upper Limit:** 7.68
- **Value:** 5.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 8
- **Value:** 5.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.3
- **Spread:** 
- **Upper Limit:** 7.3
- **Value:** 5.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.18
- **Spread:** 
- **Upper Limit:** 6.93
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.08
- **Spread:** 
- **Upper Limit:** 7.83
- **Value:** 6.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 6.25
- **Value:** 2
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 21.1
- **Spread:** 
- **Upper Limit:** 26.3
- **Value:** 24.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.6
- **Spread:** 
- **Upper Limit:** 27
- **Value:** 25.5
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.25
- **Spread:** 
- **Upper Limit:** 35
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.25
- **Spread:** 
- **Upper Limit:** 34.75
- **Value:** 22
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 226.1
- **Upper Limit:** 
- **Value:** 487
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 230.5
- **Upper Limit:** 
- **Value:** 414
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 183
- **Upper Limit:** 
- **Value:** 496
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 272
- **Upper Limit:** 
- **Value:** 569
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 243
- **Upper Limit:** 
- **Value:** 837
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 215.4
- **Upper Limit:** 
- **Value:** 508
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 213
- **Upper Limit:** 
- **Value:** 839
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 212.3
- **Upper Limit:** 
- **Value:** 585
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.7
- **Spread:** 
- **Upper Limit:** 4.5
- **Value:** 2.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.5
- **Spread:** 
- **Upper Limit:** 7.7
- **Value:** 3.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.3
- **Spread:** 
- **Upper Limit:** 4.2
- **Value:** 2.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.4
- **Spread:** 
- **Upper Limit:** 12.4
- **Value:** 6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 4.1
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 16
- **Value:** 6.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 4.5
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.6
- **Spread:** 
- **Upper Limit:** 10.4
- **Value:** 6.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.3
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.7
- **Spread:** 
- **Upper Limit:** 11.5
- **Value:** 5.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.4
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 2.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.3
- **Spread:** 
- **Upper Limit:** 5.2
- **Value:** 3.4
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.3
- **Spread:** 
- **Upper Limit:** 73.6
- **Value:** 50.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 39.4
- **Spread:** 
- **Upper Limit:** 117.5
- **Value:** 62.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 79.4
- **Spread:** 
- **Upper Limit:** 250.7
- **Value:** 154.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 111
- **Spread:** 
- **Upper Limit:** 291.2
- **Value:** 161.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 122.3
- **Spread:** 
- **Upper Limit:** 308.6
- **Value:** 195.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 150.6
- **Spread:** 
- **Upper Limit:** 448.1
- **Value:** 227.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 155.3
- **Spread:** 
- **Upper Limit:** 316.3
- **Value:** 233.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 202.4
- **Spread:** 
- **Upper Limit:** 447.2
- **Value:** 226.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 471
- **Spread:** 
- **Upper Limit:** 916.4
- **Value:** 614.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 190.1
- **Spread:** 
- **Upper Limit:** 578
- **Value:** 268.7
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 141.3
- **Spread:** 
- **Upper Limit:** 536.6
- **Value:** 357.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 106.0
- **Spread:** 
- **Upper Limit:** 575.8
- **Value:** 189.6
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.6
- **Spread:** 
- **Upper Limit:** 74
- **Value:** 30
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 34.4
- **Spread:** 
- **Upper Limit:** 87
- **Value:** 58.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -35.53
- **Spread:** 
- **Upper Limit:** 41.55
- **Value:** 7.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.4
- **Spread:** 
- **Upper Limit:** 43.85
- **Value:** 34.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.9
- **Spread:** 
- **Upper Limit:** 85.25
- **Value:** 46.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 36.8
- **Spread:** 
- **Upper Limit:** 114.73
- **Value:** 77
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.5
- **Spread:** 
- **Upper Limit:** 88.1
- **Value:** 46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18
- **Spread:** 
- **Upper Limit:** 93.2
- **Value:** 43
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 29.9
- **Spread:** 
- **Upper Limit:** 165
- **Value:** 62.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.3
- **Spread:** 
- **Upper Limit:** 153.5
- **Value:** 59
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 1.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 1.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 37.5
- **Spread:** 
- **Upper Limit:** 91.7
- **Value:** 54.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 52.5
- **Spread:** 
- **Upper Limit:** 216.5
- **Value:** 124
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.4
- **Spread:** 
- **Upper Limit:** 25.3
- **Value:** 10.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.9
- **Spread:** 
- **Upper Limit:** 56.7
- **Value:** 20.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.7
- **Spread:** 
- **Upper Limit:** 7.9
- **Value:** 4.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 20.9
- **Value:** 10.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.2
- **Spread:** 
- **Upper Limit:** 3.6
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 6.7
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.8
- **Spread:** 
- **Upper Limit:** 2.3
- **Value:** 1.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.2
- **Spread:** 
- **Upper Limit:** 9.8
- **Value:** 2.3
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.2
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.6
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.3
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 2.1
- **Value:** 0.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 0.5
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 3.5
- **Value:** 0.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 0.8
- **Value:** 0.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 2
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.5
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 1.6
- **Value:** 0.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.3
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.8
- **Value:** 0.4
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.1
- **Spread:** 
- **Upper Limit:** 0.2
- **Value:** 0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.1
- **Spread:** 
- **Upper Limit:** 0.7
- **Value:** 0.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.4
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 0.4
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 0.6
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.4
- **Spread:** 
- **Upper Limit:** 0.6
- **Value:** 0.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 0.5
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.3
- **Value:** 0.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.5
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.3
- **Spread:** 
- **Upper Limit:** 1.4
- **Value:** 0.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.6
- **Value:** 0.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.2
- **Spread:** 
- **Upper Limit:** 0.4
- **Value:** 0.3
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.1
- **Spread:** 
- **Upper Limit:** 5.5
- **Value:** 2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.4
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 3.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.6
- **Spread:** 
- **Upper Limit:** 16.2
- **Value:** 10.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.9
- **Spread:** 
- **Upper Limit:** 30.7
- **Value:** 17.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.6
- **Spread:** 
- **Upper Limit:** 46.5
- **Value:** 32.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 33.8
- **Spread:** 
- **Upper Limit:** 84.9
- **Value:** 52.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 29.6
- **Spread:** 
- **Upper Limit:** 64.8
- **Value:** 43.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 36.6
- **Spread:** 
- **Upper Limit:** 86.6
- **Value:** 49.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.6
- **Spread:** 
- **Upper Limit:** 50.4
- **Value:** 26.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.2
- **Spread:** 
- **Upper Limit:** 81.3
- **Value:** 40.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 21.5
- **Value:** 15.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.5
- **Spread:** 
- **Upper Limit:** 24.8
- **Value:** 15.5
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.4
- **Spread:** 
- **Upper Limit:** 22.7
- **Value:** 18.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.8
- **Spread:** 
- **Upper Limit:** 23.4
- **Value:** 17.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 58.8
- **Spread:** 
- **Upper Limit:** 131
- **Value:** 76.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 99.9
- **Spread:** 
- **Upper Limit:** 255.5
- **Value:** 163
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.6
- **Spread:** 
- **Upper Limit:** 162.3
- **Value:** 116.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 71
- **Spread:** 
- **Upper Limit:** 214.8
- **Value:** 147.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 36.7
- **Spread:** 
- **Upper Limit:** 131
- **Value:** 67.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 50
- **Spread:** 
- **Upper Limit:** 132
- **Value:** 90
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 40.3
- **Spread:** 
- **Upper Limit:** 61.7
- **Value:** 47.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 33.4
- **Spread:** 
- **Upper Limit:** 112.8
- **Value:** 46
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.6
- **Spread:** 
- **Upper Limit:** 59.8
- **Value:** 33.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.6
- **Spread:** 
- **Upper Limit:** 64.7
- **Value:** 38.2
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.9
- **Spread:** 
- **Upper Limit:** 3.4
- **Value:** 2.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.4
- **Spread:** 
- **Upper Limit:** 4
- **Value:** 2.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 3.8
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.5
- **Spread:** 
- **Upper Limit:** 6.4
- **Value:** 4.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.6
- **Spread:** 
- **Upper Limit:** 5.6
- **Value:** 3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 5.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 3.4
- **Value:** 3.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.7
- **Spread:** 
- **Upper Limit:** 5.5
- **Value:** 4.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 3.4
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 3.2
- **Value:** 2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.1
- **Spread:** 
- **Upper Limit:** 4.8
- **Value:** 3.5
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.8
- **Spread:** 
- **Upper Limit:** 52.1
- **Value:** 33.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.5
- **Spread:** 
- **Upper Limit:** 144.3
- **Value:** 101.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 45.6
- **Spread:** 
- **Upper Limit:** 263.3
- **Value:** 136.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 114.5
- **Spread:** 
- **Upper Limit:** 384.2
- **Value:** 201.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 193.4
- **Spread:** 
- **Upper Limit:** 446.8
- **Value:** 279.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 84.4
- **Spread:** 
- **Upper Limit:** 513.2
- **Value:** 221.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 143.1
- **Spread:** 
- **Upper Limit:** 510.2
- **Value:** 387.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 149.4
- **Spread:** 
- **Upper Limit:** 434.3
- **Value:** 300.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 598.3
- **Spread:** 
- **Upper Limit:** 2181.1
- **Value:** 1613.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 170.4
- **Spread:** 
- **Upper Limit:** 984.2
- **Value:** 366.9
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.15
- **Upper Limit:** 
- **Value:** 0.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.17
- **Upper Limit:** 
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.28
- **Upper Limit:** 
- **Value:** 0.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.38
- **Upper Limit:** 
- **Value:** 0.7
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.65
- **Upper Limit:** 
- **Value:** 1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.75
- **Upper Limit:** 
- **Value:** 1.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4
- **Upper Limit:** 
- **Value:** 5.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.54
- **Upper Limit:** 
- **Value:** 5.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The primary endpoint of this study is incidence of post-operative infections through hospital discharge
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** until Hospital Discharge, an average of 30 days
**Title:** Post-Operative Infections
**Type:** PRIMARY
**Unit of Measure:** subjects
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 2
**Description:** Any positive culture or treatment for culture negative sepsis within 1 week of surgery
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** within 1 week of surgery
**Title:** Post-operative Infection
**Type:** PRIMARY
**Unit of Measure:** Subjects
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 3
**Description:** Any positive blood culture during the post-operative period until hospital discharge
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** until Hospital Discharge, an average of 30 days
**Title:** Blood Stream Infection
**Type:** PRIMARY
**Unit of Measure:** subjects
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 7 days
**Title:** Blood Stream Infection Within 1 Week of Surgery
**Type:** PRIMARY
**Unit of Measure:** subjects
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 5
**Description:** Plasma albumin will be assessed at 24 and 48 hours.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** up to 48 hours post CPB
**Title:** Post-operative Plasma Albumin
**Type:** SECONDARY
**Unit of Measure:** g/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 6
**Description:** The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 0-24 hours post-CPB
**Title:** Fluid Overload Variables
**Type:** SECONDARY
**Unit of Measure:** mililiters/kilogram
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 7
**Description:** The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a "normal" scale or range used for this calculation.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** first 48 hours post-CPB
**Title:** Post-operative Inotrope Score
**Type:** SECONDARY
**Unit of Measure:** inotropic score
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 8
**Description:** Alive, ventilator free days will be recorded at hospital discharge.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** until Hospital Discharge, an average of 30 days
**Title:** Respiratory Variables
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 9
**Description:** From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Approximately 1 month
**Title:** Hospital Discharge
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 10
**Description:** Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 5 days post-op
**Title:** Plasma Immunoglobulins
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 11
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Pre-operative to 48 hours post-operative
**Title:** Interferon-gamma Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 12
**Description:** Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 24 hours post-op
**Title:** Immunoglobulin Concentration in Chest Tube Drainage
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 13
**Description:** Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Approximately 1 month
**Title:** Mortality
**Type:** SECONDARY
**Unit of Measure:** subjects
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 14
**Description:** The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 1 month
**Title:** Intensive Care Unit Length of Stay
**Type:** SECONDARY
**Unit of Measure:** hours
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 15
**Description:** The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 0-48 hours post-CPB
**Title:** Fluid Overload Variables
**Type:** SECONDARY
**Unit of Measure:** militers/kilogram
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 16
**Description:** Time until first extubation in hours
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** until extubation, an average of 2 days
**Title:** Respiratory Variables
**Type:** SECONDARY
**Unit of Measure:** hours
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 17
**Description:** Total time duration of post-operative length of mechanical ventilation until hospital discharge
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** until extubation, an average of 2 days
**Title:** Respiratory Variables
**Type:** SECONDARY
**Unit of Measure:** hours
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 18
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Interleukin-10 Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 19
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Interleukin-12p70 Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 20
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Interleukin-1b Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 21
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Interleukin-6 Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 22
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Interleukin-8 Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 23
**Description:** Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 48 hours post-operative
**Title:** Tumor Necrosis Factor Plasma Cytokine Levels
**Type:** SECONDARY
**Unit of Measure:** pg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 24
**Description:** Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 24 hours post-op
**Title:** Immunoglobulin Concentration in Peritoneal Dialysis Drainage
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 25
**Description:** Pre-operative and 48 hour post-operative maximum creatinine recorded.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 48 hours
**Title:** Serum Creatinine
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
#### Outcome Measure 26
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** pre-operative through 24 hours post-operative
**Title:** Lactic Acid
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** OG000
**Title:** IVIG
##### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** OG001
**Title:** Normal Saline
### Participant Flow Module
#### Group
**Description:** Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.

IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
**ID:** FG000
**Title:** IVIG
#### Group
**Description:** Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.

Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
**ID:** FG001
**Title:** Normal Saline
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True