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

May 10, 2024 updated by: Furkan Tontu, Başakşehir Çam & Sakura City Hospital
We evaluated the ability of shock indices and hemodynamic parameters to predict 28-day ICU mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Basaksehir Cam Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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."

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shock Index (SI)
Time Frame: During the first 7 hours in the ICU
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)
Time Frame: During the first 7 hours in the ICU
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)
Time Frame: During the first 7 hours in the ICU
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)
Time Frame: During the first 7 hours in the ICU
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate (HR)
Time Frame: During the first 7 hours in the ICU
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
Systolic Arterial Blood Pressure (ABPsys)
Time Frame: During the first 7 hours in the ICU
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
Diastolic Arterial Blood Pressure (ABPdias)
Time Frame: During the first 7 hours in the ICU
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
Mean Arterial Blood Pressure (ABPmean)
Time Frame: During the first 7 hours in the ICU
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
Age
Time Frame: During the first 7 hours in the ICU
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Başakşehir Çam & Sakura City Hospital

Collaborators

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-24-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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