Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in the ICU: The SOFA2-GIS Study

Starting soon

Conditions studied: Critical Illness, Multiple Organ Failure, Gastrointestinal Diseases, Mortality

In brief

The goal of this observational study is to learn whether adding a gastrointestinal (GI) component to a widely used organ failure score improves the prediction of death risk in critically ill adults treated in the intensive care unit (ICU). The Sequential Organ Failure Assessment 2 (SOFA2) score is used in ICUs to measure how severely a patient's organs are failing. The current version evaluates six organ systems but does not include the gastrointestinal system, even though gut dysfunction is common and serious in critically ill patients. Researchers in this study will add a GI subscore based on the European Society of Intensive Care Medicine (ESICM) Acute Gastrointestinal Injury (AGI) classification and create a new combined score called SOFA2-GIS. The main questions this study aims to answer are: Does adding a gastrointestinal subscore to the SOFA2 score improve the prediction of 28-day mortality in ICU patients? Does the new SOFA2-GIS score perform better than the standard SOFA2 score in identifying patients at higher risk of dying in the ICU or in the hospital? Researchers will compare the standard SOFA2 score with the new SOFA2-GIS score in the same patients to see which one better predicts patient outcomes. Participants will: Receive their usual ICU care without any change, additional treatment, or extra tests Be evaluated using routinely collected clinical and laboratory information during the first 24 hours of ICU admission Be followed during their hospital stay to record outcomes such as length of stay, need for mechanical ventilation, need for dialysis, and survival This is a multicenter, prospective, observational cohort study conducted in tertiary ICUs in Türkiye. No additional procedures, tests, or interventions will be performed for the purpose of this study.

Key facts

Study ID

NCT07586254

Run by

Ozkul Yilmaz Colak

People needed

800

Starts

2026-07-01

Expected to finish

2027-03-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older
• Admission to a participating intensive care unit
• Expected ICU length of stay of at least 24 hours
• Availability of clinical and laboratory data required to calculate the SOFA2 score and the AGI grade within the first 24 hours of ICU admission
• Written informed consent obtained from the patient or, when not feasible due to the patient's clinical condition, from a legally authorized representative

You may not qualify if…

• Age younger than 18 years
• Pregnancy
• ICU length of stay shorter than 24 hours (including patients who die or are discharged within the first 24 hours)
• ICU readmission during the same hospital stay (only the index admission will be included)
• Postoperative admission for routine monitoring without organ dysfunction (planned short-term observation following elective surgery)
• Admission solely for end-of-life care or with treatment limitations (do-not-resuscitate or withdrawal of life-sustaining therapy decisions) made within the first 24 hours of admission
• Patients with primary gastrointestinal pathology as the reason for ICU admission that would confound AGI grading (e.g., gastrointestinal surgery within the preceding 7 days, acute mesenteric ischemia as the primary diagnosis)
• Patients with anatomical or functional conditions precluding standard AGI assessment (e.g., short bowel syndrome, permanent gastrostomy/jejunostomy with chronic feeding intolerance, chronic intestinal pseudo-obstruction)
• Refusal of consent by the patient or legal representative
• Participation in an interventional clinical trial that may affect outcome measures

Where it is running

• Ondokuz Mayis University — Samsun, Atakum, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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