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

Sponsor
Marmara University
Study ID
NCT07300306
Status
Recruiting
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Conditions

  • Critical Illness
  • Organ Dysfunction
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Dec 23, 2025
Start date
May 4, 2026
Status verified
Dec 2025
Primary completion
Jun 9, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: Primary Validation Cohort
    Adult patients admitted to the ICU during the 7-day prospective recruitment window. Organ dysfunction scores are calculated within the first 24 hours to validate SOFA-2 for 30-day mortality.
  • Arm: Point Prevalence Cohort
    All adult patients present in the ICU on the designated single "Index Day" (08:00 to 08:00). Used specifically to determine the point prevalence of Sepsis-3 and septic shock.

Primary Outcome Measure

0-Day All-Cause Mortality [ Time Frame: 30 days ]

Central Contacts

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