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Validation of the SOFA-2 Score for 30-Day Mortality in Intensive Care Units in Turkey and Determination of Sepsis-3 Prevalence - A Multicenter Hybrid Observational Study.

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Marmara University Pendik Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Mustafa Kemal Arslantaş, Prof. Dr.
mkarslantas@gmail.com
+90 505 224 2119
Backup
Fethi Gül, Assoc. Prof.
gulfethi@gmail.com
+90 505 600 03 85
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2026-07
Participants
Target number of participants: 2500
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Marmara University

This content was sourced from clinicaltrials.gov