[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ozkul Yilmaz Colak\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100639232","adding-a-gastrointestinal-subscore-to-sofa2-for-mortality-risk-assessment-in-the-icu-the-sofa2-gis-study-100639232",false,"NCT07586254","Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in the ICU: The SOFA2-GIS Study","Development and Validation of the SOFA2-GIS Score: Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in Critically Ill Patients - A Multicenter Prospective Observational Cohort Study","SOFA2-GIS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to a participating intensive care unit\n* Expected ICU length of stay of at least 24 hours\n* Availability of clinical and laboratory data required to calculate the SOFA2 score and the AGI grade within the first 24 hours of ICU admission\n* Written informed consent obtained from the patient or, when not feasible due to the patient's clinical condition, from a legally authorized representative\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Pregnancy\n* ICU length of stay shorter than 24 hours (including patients who die or are discharged within the first 24 hours)\n* ICU readmission during the same hospital stay (only the index admission will be included)\n* Postoperative admission for routine monitoring without organ dysfunction (planned short-term observation following elective surgery)\n* 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\n* 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)\n* Patients with anatomical or functional conditions precluding standard AGI assessment (e.g., short bowel syndrome, permanent gastrostomy\u002Fjejunostomy with chronic feeding intolerance, chronic intestinal pseudo-obstruction)\n* Refusal of consent by the patient or legal representative\n* Participation in an interventional clinical trial that may affect outcome measures","ALL","18 Years",{"count":20,"type":21},800,"ESTIMATED","3 Months","OBSERVATIONAL","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).\n\nThe 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.\n\nThe main questions this study aims to answer are:\n\nDoes 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?\n\nResearchers will compare the standard SOFA2 score with the new SOFA2-GIS score in the same patients to see which one better predicts patient outcomes.\n\nParticipants will:\n\nReceive 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\n\nThis 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.",[26,27,28,29],"Critical Illness","Multiple Organ Failure","Gastrointestinal Diseases","Mortality",[31,32,33,15,34,35,36],"sofa2","sofa-2","Sequential Organ Failure Assessment","Organ dysfunction score","Prognostic score","ICU mortality","NOT_YET_RECRUITING","2026-05-20",{"date":40,"type":41},"2026-05-26","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2027-03",{"name":47,"class":48},"Ozkul Yilmaz Colak","OTHER",""]