SOFA-2 Score in Turkish ICUs

NCT07338240 | Recruiting

• 1 other identifier: IGHCEAH-ICU-8
• Study Type: observational
• Target: 5,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye. SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices. In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study. The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.

Conditions

Intensive Care Unit Patients; Critically Ill Intensive Care Unit Patients

Keywords

SOFA-2 Score; Critical Illness; ICU Mortality; Prognostic Scoring System

Outcome Measures

Primary Outcomes (1)

• Association Between 24-Hour SOFA-2 Score and ICU Mortality

  The association between the total SOFA-2 score calculated within the first 24 hours of intensive care unit admission and all-cause ICU mortality. Higher scores show worse outcomes.

  60 days after ICU admission

Secondary Outcomes (1)

• Reclassification Performance of SOFA-2 Compared With SOFA

  60 days after ICU admission

Study Arms (1)

Adult ICU Patients

This cohort consists of adult patients aged 18 years or older who are admitted to participating intensive care units in Türkiye and remain in the ICU for more than 24 hours. Patients are enrolled prospectively and followed from ICU admission until ICU discharge or death. Clinical and laboratory data routinely collected during standard care are used to calculate SOFA and SOFA-2 scores. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical

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

The study population consists of adult patients admitted to participating intensive care units across Türkiye. Eligible participants are critically ill adults who require intensive care monitoring and treatment and remain in the intensive care unit for more than 24 hours. The study includes a broad and heterogeneous ICU population reflecting routine clinical practice and does not target a specific dise

You may qualify if:

• Adults aged 18 years or older
• Admission to a participating intensive care unit in Türkiye
• Intensive care unit stay longer than 24 hours

You may not qualify if:

• Patients younger than 18 years
• Pregnant patients
• Organ donors
• Patients with unknown intensive care unit discharge outcomes

Sponsors & Collaborators

• Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital: lead

Study Sites (1)

University of Health Sciences Turkey, İzmir School of Medicine, Dr. Suat Seren Chest Disease and Thoracic Surgery Training and Research Hospital, Intensive Care Unit

Izmir, İzmir, 35110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.

  PMID: 9824069 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Süleyman Yıldırım, Assoc. Prof.

CONTACT

+905057143243; deu.syldrm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Intensive Care Unit

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 13, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication Ending 5 years after publication
• Access Criteria: Supporting information and de-identified individual participant data will be made available upon reasonable request. Requests will be reviewed by the study steering committee, and access will be granted following approval of a methodologically sound proposal and execution of a data use agreement.

Locations

TU (1)