Development and Validation of Multi-Biomarkers Prognostic Models for Mortality and Functional Disability in Critically-ill Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 329
- 试验地点
- 4
- 主要终点
- Development and validation of a predictive mathematical model to predict the outcome of mortality during ICU stay
研究概览
简要总结
Prospective observational study recruiting elderly patients of 60 years and above admitted to Intensive Care Unit (ICU), to study multiple domains of biomarkers ability to predict mortality of patients during intensive care unit admission and functional disability in survivors after ICU discharge
详细描述
Study Design This is a prospective observational study to develop & validate a prognostic predictive model to predict ICU mortality (primary outcome) using Multi-Biomarkers concept. The study design for Predictive Modelling Study (Prognostic) will be "Type 2a: Nonrandom split-sample development and validation" study design according to "Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis".
3.2 Study Sites
- General ICU, Hospital Universiti Sains Malaysia
- Intensive Care Unit, Sultan Ahmad Shah Medical Center (SASMEC)
- Intensive Care Unit, Hospital Queen Elizabeth
- Intensive Care Unit, Hospital Queen Elizabeth II
3.3 Study Duration Part of the study already ongoing in General ICU, Hospital Universiti Sains Malaysia and Intensive Care Unit SASMEC. Study duration will start in both Hospital Queen Elizabeth and Hospital Queen Elizabeth II when approval from MREC is obtained. Study duration expected for 2 years, estimated to complete in the end of 2023. Tentatively, it will start on 1st of June 2022 till 31st December 2022.
3.4 Target Population: Inclusion & Exclusion Criteria 3.4.1 Inclusion Criteria
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years old and above at the time of ICU admission
排除标准
- •Second or subsequent ICU admission in the same Hospital admission
结局指标
主要结局
Development and validation of a predictive mathematical model to predict the outcome of mortality during ICU stay
时间窗: From admission to intensive care unit until discharge from ICU, up to 30-days, whichever came first.
Outcome of mortality at ICU discharge, up to 30-days.
次要结局
- Development of predictive modelling to predict severe functional disability in ICU survivors(Measured at 1 year after ICU discharged among those patients discharged alive from the hospital)
研究者
Abdul Jabbar Bin Ismail
Principal Investigator
Clinical Research Centre, Malaysia