## Protocol Section
### Identification Module
**NCT ID:** NCT06415006

**Brief Title:** Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?

**Official Title:** Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?

#### Organization Study ID Info
**ID:** 2023-24-20
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-01

**Type:** ACTUAL

#### Start Date
**Date:** 2012-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Furkan Tontu

**Investigator Title:** Doctor of Anesthesiology and Reanimation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** We evaluated the ability of shock indices and hemodynamic parameters to predict 28-day ICU mortality.

**Detailed Description:** Shock indices and hemodynamic parameters are significant determinants of mortality in adult ICU patients. This study aimed to evaluate the potential of four known shock indices Shock Index (SI), Age-adjusted Shock Index (aSI), Diastolic Shock Index (dSI), and hemodynamic parameters including Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), and Mean Arterial Blood Pressure (ABPmean) in predicting 28-day ICU mortality in patients diagnosed with sepsis and septic shock.

### Conditions Module

**Conditions:**

- Shock, Septic

- Hemodynamic Instability

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1522

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The group consists of 1,522 patients treated in the intensive care unit for sepsis/septic shock.

**Intervention Names:**

- Procedure: Measurement of hemodynamic parameters.

**Label:** Group Sepsis

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group Sepsis

**Description:** The measurement and recording of Heart Rate (HR), Systolic Arterial Blood Pressure (ABPsys), Diastolic Arterial Blood Pressure (ABPdias), Mean Arterial Blood Pressure (ABPmean), and age parameters.

**Name:** Measurement of hemodynamic parameters.

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The predictive power of the Shock Index (SI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Shock Index (SI)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the Age-adjusted Shock Index (aSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Age-adjusted Shock Index (aSI)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the Diastolic Shock Index (dSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Diastolic Shock Index (dSI)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the modified Shock Index (mSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** modified Shock Index (mSI)

**Time Frame:** During the first 7 hours in the ICU

#### Secondary Outcomes

**Description:** The predictive power of the Heart Rate (HR) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Heart Rate (HR)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the Systolic Arterial Blood Pressure (ABPsys) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Systolic Arterial Blood Pressure (ABPsys)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the Diastolic Arterial Blood Pressure (ABPdias) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Diastolic Arterial Blood Pressure (ABPdias)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the Mean Arterial Blood Pressure (ABPmean) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Mean Arterial Blood Pressure (ABPmean)

**Time Frame:** During the first 7 hours in the ICU

**Description:** The predictive power of the age for 28-day mortality in sepsis patients treated in the intensive care unit.

**Measure:** Age

**Time Frame:** During the first 7 hours in the ICU

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients with a preliminary diagnosis of sepsis/septic shock in the intensive care unit
2. Adult patients aged between 18 and 80 years

Exclusion Criteria:

1. Patients under 18 years old
2. Pregnant patients
3. Patients suspected of having COVID-19 pneumonia
4. Patients with incomplete data
5. Patients for whom outcome information is unavailable due to referral to an external center
6. Patients with confirmed COVID-19, validated by thoracic computed tomography images and nasal swab PCR results
7. Patients discharged from the intensive care unit within 24 hours

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** "1,522 patients treated for sepsis/septic shock in the Anesthesiology and Reanimation intensive care unit at Bakırköy Dr. Sadi Konuk Training and Research Hospital."

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Basaksehir Cam Sakura City Hospital

### IPD Sharing Statement Module

**Description:** Not decided yet

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Sadeh R, Shashar S, Shaer E, Slutsky T, Sagy I, Novack V, Zeldetz V. Modified Shock Index as a Predictor for Mortality and Hospitalization Among Patients With Dementia. J Emerg Med. 2022 May;62(5):590-599. doi: 10.1016/j.jemermed.2021.12.023. Epub 2022 Feb 16.

**PMID:** 35181187

**Citation:** Bondariyan N, Vakhshoori M, Sadeghpour N, Shafie D. Prognostic Value of Shock Index, Modified Shock Index, and Age-Adjusted Derivatives in Prediction of In-Hospital Mortality in Patients with Acute Decompensated Heart Failure: Persian Registry of Cardiovascular Disease/ Heart Failure Study. Anatol J Cardiol. 2022 Mar;26(3):210-217. doi: 10.5152/AnatolJCardiol.2021.671.

**PMID:** 35346907

**Citation:** Pramudyo M, Marindani V, Achmad C, Putra ICS. Modified Shock Index as Simple Clinical Independent Predictor of In-Hospital Mortality in Acute Coronary Syndrome Patients: A Retrospective Cohort Study. Front Cardiovasc Med. 2022 Jun 9;9:915881. doi: 10.3389/fcvm.2022.915881. eCollection 2022.

**PMID:** 35757344

**Citation:** Kurt E, Bahadirli S. The Usefulness of Shock Index and Modified Shock Index in Predicting the Outcome of COVID-19 Patients. Disaster Med Public Health Prep. 2022 Aug;16(4):1558-1563. doi: 10.1017/dmp.2021.187. Epub 2021 Jun 8.

**PMID:** 34099089

**Citation:** Gokcek K, Gokcek A, Demir A, Yildirim B, Acar E, Alatas OD. In-hospital mortality of acute pulmonary embolism: Predictive value of shock index, modified shock index, and age shock index scores. Med Clin (Barc). 2022 Apr 22;158(8):351-355. doi: 10.1016/j.medcli.2021.04.035. Epub 2021 Aug 14. English, Spanish.

**PMID:** 34404518

**Citation:** Kocaoglu S, Karadas A. Comparison of the Effectiveness of Shock Index, Modified Shock Index, and Age Shock Index in COPD Exacerbations. J Coll Physicians Surg Pak. 2022 Sep;32(9):1187-1190. doi: 10.29271/jcpsp.2022.09.1187.

**PMID:** 36089718

**Citation:** Vang M, Ostberg M, Steinmetz J, Rasmussen LS. Shock index as a predictor for mortality in trauma patients: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2559-2566. doi: 10.1007/s00068-022-01932-z. Epub 2022 Mar 8.

**PMID:** 35258641

**Citation:** Zhang TN, Hao PH, Gao SY, Liu CF, Yang N. Evaluation of SI, MSI and DSI for very early (3-day) mortality in patients with septic shock. Eur J Med Res. 2022 Nov 3;27(1):227. doi: 10.1186/s40001-022-00857-y.

**PMID:** 36329534

**Citation:** Althunayyan SM, Alsofayan YM, Khan AA. Shock index and modified shock index as triage screening tools for sepsis. J Infect Public Health. 2019 Nov-Dec;12(6):822-826. doi: 10.1016/j.jiph.2019.05.002. Epub 2019 May 18.

**PMID:** 31113741

**Citation:** Georgette N, Michelson K, Monuteaux M, Eisenberg M. A Temperature- and Age-Adjusted Shock Index for Emergency Department Identification of Pediatric Sepsis. Ann Emerg Med. 2023 Oct;82(4):494-502. doi: 10.1016/j.annemergmed.2023.03.026. Epub 2023 May 12.

**PMID:** 37178098

**Citation:** Gupta S, Alam A. Shock Index-A Useful Noninvasive Marker Associated With Age-Specific Early Mortality in Children With Severe Sepsis and Septic Shock: Age-Specific Shock Index Cut-Offs. J Intensive Care Med. 2020 Oct;35(10):984-991. doi: 10.1177/0885066618802779. Epub 2018 Oct 2.

**PMID:** 30278814

**Citation:** Avci M, Doganay F. Prognostic Performance of Shock Index, Diastolic Shock Index, Age Shock Index, and Modified Shock Index in COVID-19 Pneumonia. Disaster Med Public Health Prep. 2022 May 2;17:e189. doi: 10.1017/dmp.2022.110.

**PMID:** 35492010

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018805

- Term: Sepsis

- ID: D000007239

- Term: Infections

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: HIGH

- As Found: Shock

- ID: M15580

- Name: Shock, Septic

- Relevance: HIGH

- As Found: Shock, Septic

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012772

- Term: Shock, Septic

- ID: D000012769

- Term: Shock

### Misc Info Module

- Version Holder: 2024-05-31
