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NCT Number: NCT07338240

SOFA-2 Score in Turkish ICUs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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)

Location status: Recruiting

Location contact

Süleyman Yıldırım, Assoc. Prof.

CONTACT

[email protected]

05057143243

About this study

This is a multicenter, prospective, observational study designed to evaluate the feasibility and prognostic performance of the Sequential Organ Failure Assessment-2 (SOFA-2) score in adult intensive care units across Türkiye.

Adult patients aged 18 years or older who are admitted to participating intensive care units and remain in the ICU for more than 24 hours will be eligible for inclusion. Pregnant patients, organ donors, patients younger than 18 years, and those with unknown ICU discharge outcomes will be excluded.

Demographic characteristics, reasons for ICU admission, comorbid conditions, and routinely collected clinical and laboratory data will be prospectively recorded using standardized case report forms. SOFA and SOFA-2 scores will be calculated based on data obtained during the first 24 hours following ICU admission. For patients with an ICU stay longer than 72 hours, additional SOFA and SOFA-2 scores will be recorded at 72 hours.

Patients will be followed until ICU discharge or death. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical management will be implemented as part of the study.

The study will assess the feasibility of real-time SOFA-2 score calculation, evaluate its association with ICU mortality, and compare its prognostic performance with the original SOFA score. Analyses will account for the multicenter structure of the study and variations across participating intensive care units.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Association Between 24-Hour SOFA-2 Score and ICU Mortality

    Time frame: 60 days after ICU admission

    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.

Secondary outcomes

  1. Reclassification Performance of SOFA-2 Compared With SOFA

    Time frame: 60 days after ICU admission

    Comparison of patient risk classification between SOFA and SOFA-2 scores with respect to ICU mortality.Higher scores show worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Süleyman Yıldırım, Assoc. Prof.

CONTACT

[email protected]

+905057143243

Sponsors and collaborators

Lead sponsor

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

Other

Registry information

Official study title

Real-Time Validation and Feasibility of the SOFA-2 Score in Adult Intensive Care Units in Türkiye (TR-SOFA2): A Multicenter Prospective Observational Study

Acronym: TR-SOFA2

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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