Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey (TURK-SOFA2)

May 4, 2026 updated by: Mustafa Kemal Arslantas, Marmara University

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.

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background and Rationale Sepsis remains a leading cause of mortality in Intensive Care Units (ICUs) globally. The operational definition of sepsis (Sepsis-3) relies on the Sequential Organ Failure Assessment (SOFA) score. However, the original SOFA score, developed in 1996, predates modern critical care interventions such as High-Flow Nasal Cannula (HFNC), non-invasive ventilation, and contemporary vasopressor strategies. Consequently, the original score has limitations in accurately characterizing organ dysfunction in the modern ICU setting.

The recently updated SOFA-2 score (JAMA, 2025) addresses these shortcomings by revising scoring thresholds and incorporating modern respiratory and cardiovascular support modalities. While validated in large international cohorts, the SOFA-2 score requires local validation in Turkey to account for regional differences in patient demographics, genetics, and healthcare infrastructure before widespread clinical adoption.

Study Design This is a multicenter, prospective, hybrid observational study comprising two distinct components to maximize data utility while minimizing data collection burden:

Prospective Validation Cohort (Primary): A 7-day recruitment window will be established (e.g., January 2026). During this period, all consecutive adult patients (aged 18 and older) admitted to participating ICUs will be enrolled. Baseline organ dysfunction scores will be calculated using the worst physiological values recorded during the first 24 hours of admission. These patients will be followed up for 30-day all-cause mortality to validate the predictive performance (discrimination and calibration) of the SOFA-2 score compared to the original SOFA-1 score.

Point-Prevalence Cohort (Secondary): Within the 7-day window, a specific 24-hour period will be designated as the "Index Day." This cross-sectional component will include all patients present in the ICU at 08:00 AM on the index day, plus any new admissions over the subsequent 24 hours. This cohort will be used specifically to determine the point prevalence of Sepsis-3 and septic shock in Turkish ICUs, providing a snapshot of the current epidemiological burden compared to historical data.

Data Collection Methodology To ensure standardization and eliminate inter-rater variability, participating centers will not manually calculate scores. Instead, researchers will record raw physiological, laboratory, and therapeutic variables (e.g., PaO2, platelet count, exact vasopressor doses, Glasgow Coma Scale) into a central electronic Case Report Form (eCRF). The study algorithms will then centrally and automatically calculate SOFA-1, SOFA-2, APACHE II, and Sepsis-3 status for all patients. This approach ensures that the comparison between scoring systems is objective and mathematically consistent.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Fethi Gül, Assoc. Prof.
  • Phone Number: +90 505 600 03 85
  • Email: gulfethi@gmail.com

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34912
        • Recruiting
        • Marmara University Pendik Training and Research Hospital
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (aged 18 years or older) admitted to adult Intensive Care Units (ICUs) in participating University Hospitals, Training and Research Hospitals, State Hospitals, and Private Hospitals across Turkey. The population includes consecutive admissions with various critical illness etiologies, excluding those admitted to coronary or cardiovascular surgery units.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
0-Day All-Cause Mortality
Time Frame: 30 days
The vital status (alive or dead) of patients assessed at 30 days post-ICU admission. This measure is used to validate the predictive accuracy (discrimination and calibration) of the SOFA-2 score.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence of Sepsis-3
Time Frame: Index Day (24 hours)
The proportion of patients meeting the Third International Consensus Definitions for Sepsis (Sepsis-3) in the ICU on the designated index day.
Index Day (24 hours)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor-Free Days (VFD-28)
Time Frame: 28 days
The number of days alive and free of vasopressor therapy within the first 28 days following admission.
28 days
Length of ICU Stay
Time Frame: From date of admission until the date of discharge or death, assessed up to 90 days.
The duration of stay in the Intensive Care Unit from admission to discharge or death.
From date of admission until the date of discharge or death, assessed up to 90 days.
Length of Hospital Stay
Time Frame: From date of admission until the date of discharge or death, assessed up to 90 days.
The total duration of hospitalization from admission to discharge or death.
From date of admission until the date of discharge or death, assessed up to 90 days.

Collaborators and Investigators

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

Sponsor

Marmara University

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

Helpful Links

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)

May 4, 2026

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TURK-SOFA2
  • 09.2025.25-1065 (Other Identifier: Marmara University School of Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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