Real-Time Validation and Feasibility of the SOFA-2 Score in Adult Intensive Care Units in Türkiye (TR-SOFA2): A Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,200
- 试验地点
- 1
- 主要终点
- Association Between 24-Hour SOFA-2 Score and ICU Mortality
研究概览
简要总结
This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye.
SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices.
In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study.
The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.
详细描述
This is a multicenter, prospective, observational study designed to evaluate the feasibility and prognostic performance of the Sequential Organ Failure Assessment-2 (SOFA-2) score in adult intensive care units across Türkiye.
Adult patients aged 18 years or older who are admitted to participating intensive care units and remain in the ICU for more than 24 hours will be eligible for inclusion. Pregnant patients, organ donors, patients younger than 18 years, and those with unknown ICU discharge outcomes will be excluded.
Demographic characteristics, reasons for ICU admission, comorbid conditions, and routinely collected clinical and laboratory data will be prospectively recorded using standardized case report forms. SOFA and SOFA-2 scores will be calculated based on data obtained during the first 24 hours following ICU admission. For patients with an ICU stay longer than 72 hours, additional SOFA and SOFA-2 scores will be recorded at 72 hours.
Patients will be followed until ICU discharge or death. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical management will be implemented as part of the study.
The study will assess the feasibility of real-time SOFA-2 score calculation, evaluate its association with ICU mortality, and compare its prognostic performance with the original SOFA score. Analyses will account for the multicenter structure of the study and variations across participating intensive care units.
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 in Türkiye
- •Intensive care unit stay longer than 24 hours
排除标准
- •Patients younger than 18 years
- •Pregnant patients
- •Organ donors
- •Patients with unknown intensive care unit discharge outcomes
研究组 & 干预措施
Adult ICU Patients
This cohort consists of adult patients aged 18 years or older who are admitted to participating intensive care units in Türkiye and remain in the ICU for more than 24 hours. Patients are enrolled prospectively and followed from ICU admission until ICU discharge or death. Clinical and laboratory data routinely collected during standard care are used to calculate SOFA and SOFA-2 scores. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical
结局指标
主要结局
Association Between 24-Hour SOFA-2 Score and ICU Mortality
时间窗: 60 days after ICU admission
The association between the total SOFA-2 score calculated within the first 24 hours of intensive care unit admission and all-cause ICU mortality. Higher scores show worse outcomes.
次要结局
- Reclassification Performance of SOFA-2 Compared With SOFA(60 days after ICU admission)
研究者
Cenk Kirakli, M.D.
Professor, Intensive Care Unit
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital