Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International, Multicentre, Randomised, Controlled Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department With Severe Sepsis and Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,210
- 主要终点
- All-cause mortality
研究概览
简要总结
This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA) of three EGDT clinical trials.
详细描述
In 2001, Rivers and colleagues, published the results of a single-centre, proof-of-concept, randomised, controlled trial conducted in the USA comparing protocolised resuscitation, termed early goal-directed therapy (EGDT), with usual resuscitation in 263 patients presenting to the emergency department (ED) with severe sepsis or septic shock. The Rivers' trial demonstrated a significant 16% absolute risk reduction (ARR) in hospital mortality from 46.5% to 30.5%. With a view to informing the generalisability of these findings in their own health care settings, three independent, large, multicentre, randomised controlled trials testing EGDT were subsequently funded, one in the USA, one in Australasia and one in the UK:
USA - Protocolized Care for Early Septic Shock (ProCESS); Australasia - Australasian Resuscitation In Sepsis Evaluation (ARISE); and UK - Protocolised Management In Sepsis (ProMISe). Though independent trials, but with a view to performing a subsequent individual patient data meta-analysis (IPDMA), efforts were made to harmonise the three, contemporaneous trials on key areas of their design, for example, trial protocol, entry criteria, data and data collection, primary and secondary outcomes, etc.
As exist, and are published, for each of the individual trials, ProCESS, ARISE and ProMISe , the proposed IPDMA requires a pre-specified statistical analysis plan (SAP). The SAP set out below has been agreed between the three trial teams and prior to any knowledge of the results of any of the individual three trials.
It should be noted that, any proposed analyses added to the IPDMA SAP, post-knowledge of the results of ProCESS, ARISE and/or ProMISe, will be clearly indicated in any subsequent publication of the SAP and the results of this IPDMA.
Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •* Enrolled into one of the three studies (ARISE, ProMISe or ProCESS) to either Early Goal Directed Therapy or usual resuscitation
排除标准
- 未提供
结局指标
主要结局
All-cause mortality
时间窗: 90 days post-randomisation
次要结局
- Hospital mortality(At hospital discharge (censored at 60 days))
- Duration of survival(from randomisation (censored at 90 days))
- Receipt of and duration of renal replacement therapy post-randomisation(From randomisation to end of renal replacement therapy (censored at 90 days))
- 28-day mortality(At 28 days from randomisation)
- Receipt of and duration of mechanical ventilation post-randomisation(From randomisation to end of mechanical ventilation (censored at 90 days))
- Duration of stay in the Intensive Care Unit (ICU)(from ICU admission to ICU discharge (censored at 90 days))
- Duration of stay in the Emergency Department (ED)(From ED admission to ED discharge (censored at 72 hours))
- Duration of stay in the hospital(From hospital admission to hospital discharge (censored at 90 days))
- Receipt of and duration of vasopressor support post-randomisation(From randomisation to end of vasopressor support (censored at 90 days))