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

NCT06415006 | Completed

• 1 other identifier: 2023-24-20
• Study Type: observational
• Target: 1,522
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shock, Septic; Hemodynamic Instability

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Heart Rate (HR)

  During the first 7 hours in the ICU

• Systolic Arterial Blood Pressure (ABPsys)

  During the first 7 hours in the ICU

• Diastolic Arterial Blood Pressure (ABPdias)

  During the first 7 hours in the ICU

• Mean Arterial Blood Pressure (ABPmean)

  During the first 7 hours in the ICU

• Age

  During the first 7 hours in the ICU

Study Arms (1)

Group Sepsis

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

Procedure: Measurement of hemodynamic parameters.

Interventions

Measurement of hemodynamic parameters. PROCEDURE

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.

Group Sepsis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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."

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi: collaborator

Study Sites (1)

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: December 1, 2012
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)