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

NCT07586254 | Not Yet Recruiting

• 1 other identifier: ICU-SOFAGIS-2026-01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Mortality; Multiple Organ Failure; Gastrointestinal Diseases

Keywords

sofa2; sofa-2; Sequential Organ Failure Assessment; SOFA2-GIS; Organ dysfunction score; Prognostic score; ICU mortality

Outcome Measures

Primary Outcomes (1)

• Comparison of discriminative performance between SOFA2 and SOFA2-GIS scores for 28-day all-cause mortality

  The discriminative ability of the SOFA2 score (calculated within the first 24 hours of ICU admission, using worst values) and the SOFA2-GIS score (SOFA2 combined with the gastrointestinal subscore derived from the ESICM 2012 Acute Gastrointestinal Injury classification) will be compared using the area under the receiver operating characteristic curve (AUC-ROC) for predicting 28-day all-cause mortality. Statistical comparison between the two AUC values will be performed using the DeLong test. The primary outcome event is death from any cause within 28 days of ICU admission.

  28 days from ICU admission

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

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.

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

Sponsors & Collaborators

• Ozkul Yilmaz Colak: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55002, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness; Multiple Organ Failure; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Digestive System Diseases

Study Officials

• Ozkul Yilmaz Colak, MD

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Ozkul Yılmaz Colak, MD

CONTACT

905063349266; ozkulyilmaz.colak@omu.edu.tr

Melda Isevi, MD

CONTACT

drmeldaisevi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 5 years following publication of the primary results manuscript.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal, approved by the steering committee of the SOFA2-GIS study group. Proposals should be directed to the principal investigator (Dr. Mustafa Bilgiç, Ondokuz Mayıs University) and should include a statistical analysis plan and a clear scientific question. To gain access, requesters will need to sign a data access agreement, including a commitment not to attempt to re-identify participants.

Locations

TU (1)