African Surgical OutcomeS-2 (ASOS-2) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27,507
- 试验地点
- 2
- 主要终点
- In hospital mortality.
研究概览
简要总结
An international, multicentre, African cluster randomised trial.
Primary objective :
To determine whether increased postoperative surveillance in high-risk adult surgical patients reduces overall in-hospital mortality in surgical patients aged 18 years and over in Africa.
Primary outcome measure:
In-hospital mortality, censored at 30 days if the patient is still alive and in-hospital.
Secondary objective:
To determine whether increased postoperative surveillance in high-risk adult surgical patients reduces the overall incidence of the composite of severe in-hospital complications and mortality in adult surgical patients aged 18 years and over in Africa.
Secondary outcome measure:
Composite of severe in-hospital complications and mortality, censored at 30 days if the patient is still alive and in-hospital.
详细描述
Study design:
ASOS-2 is an African, international, multicentre, cluster randomised trial.
Inclusion criteria:
- Patients: All consecutive adult patients aged 18 years and over admitted to participating centres undergoing elective and non-elective surgery
- Participating surgical centres: Randomised according to a stratification based upon the level of the surgical facility and the surgical case load. Recruitment will start in May 2019.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consecutive adult patients aged 18 years and over admitted to participating centres undergoing elective and non-elective surgery
排除标准
- •Prior participation in ASOS-2
结局指标
主要结局
In hospital mortality.
时间窗: In-hospital, and censored at 30 days after surgery if still in-hospital.
Number of Participants with In hospital mortality
次要结局
- Composite of severe in-hospital complications and mortality(In-hospital, and censored at 30 days after surgery if still in-hospital.)
研究者
Bruce Biccard
Consultant Anaesthetist
University of Cape Town