## Protocol Section
### Identification Module
**NCT ID:** NCT00664079

**Acronym:** Thyroid

**Brief Title:** Thyroid Hormones in Critically Ill Children

**Official Title:** Thyroid Hormone Deficiency in Critically Ill Children

#### Organization Study ID Info
**ID:** 2005-10-4547
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Philadelphia
### Status Module
#### Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-11

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2008-06

**Type:** ACTUAL

#### Start Date
**Date:** 2005-10

**Status Verified Date:** 2008-07

#### Study First Post Date
**Date:** 2008-04-22
**Type:** ESTIMATED
**Study First Submit Date:** 2008-04-18
**Study First Submit QC Date:** 2008-04-18
**Why Stopped:** Sluggish enrollment.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Philadelphia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. We hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.

**Detailed Description:** We hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. We will measure TSH, tT3, fT3, rT3, tT4, fT4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.

### Conditions Module

**Conditions:**

- Hypotension

- Respiratory Failure

**Keywords:**

- Thyroid Deficiency

- Thyroid Stimulating Hormone

### Design Module

#### Bio Spec

**Description:** Whole blood and serum

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 22

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who are receiving vasoactive medications and/or are mechanically ventilated.

**Intervention Names:**

- Other: Blood draws

**Label:** 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 17 mls of blood will be drawn over a 5 day period from either a central venous catheter/arterial line or with scheduled phlebotomy. The following labs will be run tT3, fT3, rT#, tT4, fT4, TSH, and tyrosine.

**Name:** Blood draws

**Other Names:**

- Critically Ill Children

- Vasoactive Infusions in Children

- Mechanical Venilation in Children

- Thyroid Deficiency

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Certain critically ill children requiring vasoactive infusions and/or mechanical ventilation have low concentrations of tT3, fT3, tT4, fT4, elevated rT3, adn inappropriate low/normal TSH.

**Time Frame:** When patient has completed the study.

#### Secondary Outcomes

**Measure:** Critically ill children with more severe thyroid hormone deficiencies will have greater severity of illness, intensity of therapeutic intervention, organ dysfunction, and increased morbidity and mortality.

**Time Frame:** When study is completed.

**Measure:** Critically ill children requiring vasoactive infusions and/or mechanical ventilation are a population in the ICU that has thyroid hormone pertubation and significant morbidity and mortality.

**Time Frame:** At completion of study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Informed Consent
* Age of less than 12 months and less than or equal to 18
* Patient must weigh greater than 10 kgs.
* Patients must require vasoactive infusions and/or mechanical ventilation.
* Patients must be enrolled within 24 hours of meeting eligibility.

Exclusion Criteria:

* Patient with known or presumed pre-existing thyroid disease will be excluded
* Patients who receive thyroid supplementation will be excluded
* Patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness.
* Patients who are intubated for airway protection only.
* Patients intubated for neuromuscular disease
* Pregnant patients.
* Patients receiving amiodarone supplementation
* Patients who received blood product transfusions equaling more than 1/2 of their blood volume.

**Maximum Age:** 18 Years

**Minimum Age:** 12 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Patients who are admitted to the Pediatric Intensive Care Unit at the Children's Hospital of Philadelphia will be approached if they meet inclusion criteria.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia,

**Country:** United States

**Facility:** The Children's Hospital of Philadelphia

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital of Philadelphia

**Name:** Athena Zuppa, MD, MSCE

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: HIGH

- As Found: Respiratory Failure

- ID: M10072

- Name: Hypotension

- Relevance: HIGH

- As Found: Hypotension

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19010

- Name: Critical Illness

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012131

- Term: Respiratory Insufficiency

- ID: D000007022

- Term: Hypotension

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
