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

Completed

• Conditions: Shock, Septic; Hemodynamic Instability
• Interventions: Procedure: Measurement of hemodynamic parameters.

• Registration Number: NCT06415006
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study Start: 2012-12-01
• Primary Completion: 2023-11-01
• Study Completion: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1522

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Sepsis	Measurement of hemodynamic parameters.	The group consists of 1,522 patients treated in the intensive care unit for sepsis/septic shock.

Primary Outcome Measures

Name	Time	Method
Age-adjusted Shock Index (aSI)	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.
Diastolic Shock Index (dSI)	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.
Shock Index (SI)	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.
modified Shock Index (mSI)	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.

Secondary Outcome Measures

Name	Time	Method
Heart Rate (HR)	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.
Systolic Arterial Blood Pressure (ABPsys)	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.
Mean Arterial Blood Pressure (ABPmean)	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.
Diastolic Arterial Blood Pressure (ABPdias)	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.
Age	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.

Trial Locations

Locations (1)

Basaksehir Cam Sakura City Hospital; 🇹🇷 Istanbul, Turkey