Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?

Hemodynamic Instability Clinical Trial

Official title:

Can Shock Indices Be Prognostic Indicators in Sepsis/Septic Shock?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06415006
• Other study ID #: 2023-24-20
• Status: Completed
• Start date: December 1, 2012
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1522
• Est. completion date: February 1, 2024
• Est. primary completion date: November 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Shock
• Shock, Septic

Intervention

Procedure:
• Measurement of hemodynamic parameters.
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.

Locations

Country	Name	City	State
Turkey	Basaksehir Cam Sakura City Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital	SBÜ Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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. — View 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. — View 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 Cardiova — View 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. — View 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.m — View 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: 10.1177/088506661 — View 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. — View 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. — View 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 — View 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 Fe — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shock Index (SI)	The predictive power of the Shock Index (SI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Primary	Age-adjusted Shock Index (aSI)	The predictive power of the Age-adjusted Shock Index (aSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Primary	Diastolic Shock Index (dSI)	The predictive power of the Diastolic Shock Index (dSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Primary	modified Shock Index (mSI)	The predictive power of the modified Shock Index (mSI) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Secondary	Heart Rate (HR)	The predictive power of the Heart Rate (HR) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Secondary	Systolic Arterial Blood Pressure (ABPsys)	The predictive power of the Systolic Arterial Blood Pressure (ABPsys) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Secondary	Diastolic Arterial Blood Pressure (ABPdias)	The predictive power of the Diastolic Arterial Blood Pressure (ABPdias) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Secondary	Mean Arterial Blood Pressure (ABPmean)	The predictive power of the Mean Arterial Blood Pressure (ABPmean) parameter for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU
Secondary	Age	The predictive power of the age for 28-day mortality in sepsis patients treated in the intensive care unit.	During the first 7 hours in the ICU