Fluid Restricted Resuscitation in Sepsis With Hypotension Meta-Analysis (FRESHLY): Individual Patient Data Met-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS Trials
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,838
- 主要终点
- All-cause mortality at 90 days post randomisation
研究概览
简要总结
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
详细描述
This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
The investigators will include four multicentre, open-label, randomised, clinical trials:
- Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942
- Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236
- Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028
- Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499
All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.
The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Participants of the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials who had:
- •Suspected or proven infection
- •Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
- •Lactate ≥ 2.0 mmol/L
- •Requirement for vasopressors to meet perfusion targets
- •Exclusion criteria:
- •Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials
排除标准
- 未提供
结局指标
主要结局
All-cause mortality at 90 days post randomisation
时间窗: 90 days
Death from any cause at 90 days after randomisation
次要结局
- Incidence of mechanical ventilation(from randomisation until day 90 post-randomisation)
- Duration of hospital stay(From randomisation until day 90 post-randomisation)
- Time from randomisation to death(Up to day 90)
- Incidence of acute renal replacement therapy(from randomisation until day 90 post-randomisation)
- Incidence of serious adverse events(from randomisation until day 90 post-randomisation)
- Days alive free of organ support at 28 days post randomisation(from randomisation until day 28 post-randomisation)
- Duration of intensive care unit (ICU) stay(From randomisation until day 90 post-randomisation)