Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in the ICU: The SOFA2-GIS Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOzkul Yilmaz Colak
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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients (≥18 years) consecutively admitted to participating tertiary intensive care units in Türkiye. The study population includes both medical and surgical ICU admissions, with a broad mix of admission diagnoses representative of contemporary critical care practice. Patients will be enrolled regardless of underlying disease, as long as they meet eligibility criteria within the first 24 hours of ICU admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Comparison of discriminative performance between SOFA2 and SOFA2-GIS scores for 28-day all-cause mortality
The primary outcome is the difference in the area under the receiver operating characteristic curve (ΔAUC) between the SOFA2-GIS score and the SOFA2 score for predicting 28-day all-cause mortality. Both scores are calculated within the first 24 hours of ICU admission using the worst recorded values of each component. The Sequential Organ Failure Assessment 2 (SOFA2) score evaluates six organ systems (respiratory, cardiovascular, hepatic, renal, neurological, and coagulation), each scored from 0 to 4, with a total range of 0 to 24; higher scores indicate worse organ dysfunction. The SOFA2-GIS score combines SOFA2 with a gastrointestinal subscore (Grade 0-IV, scored 0-4) derived from the ESICM 2012 Acute Gastrointestinal Injury classification, with a total range of 0 to 28; higher scores indicate worse organ dysfunction. The area under the receiver operating characteristic curve (AUC-ROC) ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination); higher values indicate better
Time frame
28 days from ICU admissionSecondary outcomes
1
Difference in discriminative performance (ΔAUC) between SOFA2-GIS and SOFA2 for prediction of 90-day all-cause mortality
The difference in the area under the receiver operating characteristic curve (ΔAUC) between SOFA2-GIS and SOFA2 scores (calculated within the first 24 hours of ICU admission) will be evaluated for predicting 90-day all-cause mortality. ΔAUC = AUC(SOFA2-GIS) - AUC(SOFA2). AUC-ROC ranges from 0.5 to 1.0; ΔAUC ranges from -0.5 to +0.5, with positive values indicating better performance of SOFA2-GIS. Statistical comparison via the DeLong test.
Time frame
90 days from ICU admission2
Difference in discriminative performance (ΔAUC) between SOFA2-GIS and SOFA2 for prediction of ICU mortality
The difference in AUC-ROC between SOFA2-GIS and SOFA2 scores will be evaluated for predicting all-cause ICU mortality. ΔAUC = AUC(SOFA2-GIS) - AUC(SOFA2), ranges from -0.5 to +0.5; positive values indicate better performance of SOFA2-GIS. Statistical comparison via the DeLong test.
Time frame
Through ICU discharge, up to 60 days from ICU admission3
Difference in discriminative performance (ΔAUC) between Δ-SOFA2-GIS and Δ-SOFA2 for prediction of 28-day all-cause mortality
Δ-SOFA2 and Δ-SOFA2-GIS will be calculated as the change in scores between the 72nd hour and 24th hour of ICU admission (T72 - T24). Δ-SOFA2 ranges from -24 to +24, and Δ-SOFA2-GIS ranges from -28 to +28; positive values indicate clinical deterioration, negative values indicate improvement. The difference in AUC-ROC between Δ-SOFA2-GIS and Δ-SOFA2 for predicting 28-day all-cause mortality will be calculated as ΔAUC = AUC(Δ-SOFA2-GIS) - AUC(Δ-SOFA2), with statistical comparison via the DeLong test.
Time frame
From ICU admission to 28 days4
Net Reclassification Improvement (NRI) of SOFA2-GIS over SOFA2 for 28-day all-cause mortality
Net Reclassification Improvement (NRI) quantifies the proportion of patients reclassified into more accurate risk categories when SOFA2-GIS is used instead of SOFA2 for predicting 28-day all-cause mortality. NRI ranges from -2 to +2; positive values indicate that SOFA2-GIS improves risk classification compared with SOFA2.
Time frame
28 days from ICU admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ozkul Yilmaz Colak
Lead sponsor
Ondokuz Mayıs University
Sponsor institution
Source ClinicalTrials.gov
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