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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Background and Rationale The Sequential Organ Failure Assessment (SOFA) score, originally introduced in 1996, has been widely used to describe and monitor organ dysfunction in critically ill patients across six organ systems: respiratory, cardiovascular, hepatic, renal, neurological, and coagulation. A revised version, SOFA2, was developed in 2024 by an international consortium under the European Society of Intensive Care Medicine (ESICM) to better reflect contemporary intensive care practice and to incorporate evidence-based threshold revisions derived from large modern ICU databases.
Despite this update, SOFA2 still does not include the gastrointestinal (GI) system. Acute gastrointestinal dysfunction is highly prevalent in critically ill patients and has been independently associated with increased mortality, prolonged ICU stay, and higher rates of nosocomial infection. The Acute Gastrointestinal Injury (AGI) classification, proposed by the ESICM Working Group on Abdominal Problems in 2012, provides a structured framework to grade GI dysfunction from Grade I (increased risk of GI dysfunction) to Grade IV (life-threatening GI failure). Despite its conceptual robustness, the AGI classification has not been formally integrated into a unified organ dysfunction score.
This study aims to address this gap by developing and prospectively evaluating SOFA2-GIS - a composite score combining the SOFA2 score with a gastrointestinal subscore derived from the AGI classification - and comparing its prognostic performance against the standard SOFA2 score in adult ICU patients. The study will be reported in accordance with the TRIPOD+AI 2024 reporting standards for prediction model studies.
Study Design and Procedures
This is a multicenter, prospective, observational cohort study conducted in tertiary adult intensive care units. Eligible patients will be evaluated at two predefined time points:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Ozkul Yilmaz Colak
Principal Investigator
Ondokuz Mayıs University