About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Ozkul Yilmaz Colak
Lead sponsor
Ondokuz Mayıs University
Sponsor institution