Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey

Recruiting now

Conditions studied: Sepsis, Septic Shock, Critical Illness, Organ Dysfunction

In brief

The goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. The main questions it aims to answer are: * Does the SOFA-2 score accurately predict 30-day mortality in ICU patients? * What is the prevalence of Sepsis-3 and septic shock in Turkish ICUs? Researchers will compare the new SOFA-2 score to the existing SOFA-1 score to see if the new score provides better predictive accuracy for patient outcomes. Participants will not receive any experimental intervention. Researchers will collect data from routine medical care, including: * Vital signs, laboratory test results, and details of organ support (such as mechanical ventilation or dialysis) during the first 24 hours of admission. * Survival status at 30 days.

Key facts

Study ID

NCT07300306

Run by

Marmara University

People needed

2500

Starts

2026-05-04

Expected to finish

2026-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 years or older.
• Admitted to the Intensive Care Unit (ICU) during the specified study recruitment window.
• For the Validation Cohort: Patients staying in the ICU for at least 24 hours.
• For the Point Prevalence Cohort: Patients present in the ICU at 08:00 AM on the designated "Index Day" or admitted within the subsequent 24 hours.

You may not qualify if…

• Patients younger than 18 years of age.
• Patients admitted to Pediatric Intensive Care Units.
• Patients admitted to Coronary Care Units (CCU).
• Patients admitted to Cardiovascular Surgery Intensive Care Units.
• Patients admitted solely for the purpose of organ donation.
• Patients with missing core data components required for score calculation.

Where it is running

• Marmara University Pendik Training and Research Hospital — Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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