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

NCT07300306 | Not Yet Recruiting

• 2 other identifiers: TURK-SOFA209.2025.25-1065
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Septic Shock; Critical Illness; Organ Dysfunction

Keywords

SOFA-2 Score; Sepsis-3; Intensive Care Unit; Mortality Prediction; Organ Failure Assessment; Validation Study

Outcome Measures

Primary Outcomes (1)

• 0-Day All-Cause Mortality

  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 Outcomes (1)

• Point Prevalence of Sepsis-3

  Index Day (24 hours)

Other Outcomes (3)

• Vasopressor-Free Days (VFD-28)

  28 days

• Length of ICU Stay

  From date of admission until the date of discharge or death, assessed up to 90 days.

• Length of Hospital Stay

  From date of admission until the date of discharge or death, assessed up to 90 days.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34912, Turkey (Türkiye)

Location

Related Publications (2)

• Ranzani OT, Singer M, Salluh JIF, Shankar-Hari M, Pilcher D, Berger-Estilita J, Coopersmith CM, Juffermans NP, Laffey J, Reinikainen M, Neto AS, Tavares M, Timsit JF, Arias Lopez MDP, Arulkumaran N, Aryal D, Azoulay E, Celi LA, Chaudhuri D, De Lange D, De Waele J, Dos Santos CC, Du B, Einav S, Engelbrecht T, Fazla F, Ferrer R, Finazzi S, Fujii T, Gershengorn HB, Greene JD, Haniffa R, Hao S, Hasan MS, Hollenberg S, Ippolito M, Jung C, Kirov M, Kobari S, Lakbar I, Lipman J, Liu V, Liu X, Lobo SM, Magatti D, Martin GS, Metnitz B, Metnitz P, Myatra SN, Oczkowski S, Paiva JA, Paruk F, Pekkarinen PT, Piquilloud L, Polkki A, Prescott HC, Blaser AR, Rezende E, Robba C, Rochwerg B, Ruckly S, Samei R, Schenck EJ, Secombe P, Sendagire C, Siaw-Frimpong M, Simpkin AJ, Soares M, Summers C, Szczeklik W, Takala J, Tanaka S, Tricella G, Vincent JL, Wendon J, Zampieri FG, Rhodes A, Moreno R. Development and Validation of the Sequential Organ Failure Assessment (SOFA)-2 Score. JAMA. 2025 Dec 16;334(23):2090-2103. doi: 10.1001/jama.2025.20516.

  PMID: 41159833 RESULT

• Weijs PJM. Route, early or energy? ... Protein improves protein balance in critically ill patients. Crit Care. 2018 Apr 14;22(1):91. doi: 10.1186/s13054-018-2015-z. No abstract available.

  PMID: 29653538 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Sepsis; Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Central Study Contacts

Mustafa Kemal Arslantaş, Prof. Dr.

CONTACT

+90 505 224 2119; mkarslantas@gmail.com

Fethi Gül, Assoc. Prof.

CONTACT

+90 505 600 03 85; gulfethi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Anesthesiology and Reanimation

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: January 15, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

TU (1)