NCT02754193已完成不适用
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)
Central Hospital, Nancy, France20 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2016年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 20
- 主要终点
- All-cause Mortality
研究概览
简要总结
A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.
The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age ≥ 18 years
- •Intubated patients with cardiogenic shock treated with VA-ECMO
- •Patient affiliated to social security plan
排除标准
- •VA-ECMO after cardiac surgery for heart transplantation or lung transplantation or left or biventricular assist device implantation
- •VA-ECMO for acute poisoning with cardio-toxic drugs
- •Pregnancy
- •Uncontrolled bleeding (bleeding despite medical intervention (surgery or drugs))
- •Implantation of VA ECMO under cardiac massage with a duration of cardiac massage >45minutes
- •Out of hospital refractory cardiac arrest
- •Cerebral deficit with fixed dilated pupils
- •Participation in another interventional research involving therapeutic modifications
- •Patient moribund on the day of randomization
- •Irreversible neurological pathology
- •Minor patients
- •Patients under tutelage
结局指标
主要结局
All-cause Mortality
时间窗: Day 30
The study objective is to determine whether early moderate hypothermia (33°C≤ T°C ≤34°C) is superior to normothermia (37°C ± 0.3°C) in patients with cardiogenic shock treated with VA-ECMO with respect to 30-day mortality
次要结局
- Death(day 30, Day 60, Day 180)
- Lactate(up to 180 days (from date of randomization until ECMO weaning))
- Mechanical ventilation(baseline, day 30, day 60 and day 180)
- Renal replacement therapy(from baseline until day 30, day 60, day 180)
- packed red blood cells transfused(Hour 48, Day 7)
- All-cause mortality(Hour 48, Day 7, Day 60, day 180)
- Stroke(Day 30, Day 60, Day 180)
- Venous Arterial ECMO duration(up to 180 days (from date of randomization until ECMO weaning))
- cardiac transplant(day 30, Day 60, Day 180)
- SOFA score(from baseline until Day 30)
- Intensive care unit stay(Day 30; Day 60; Day 180)
- escalation to Left Ventricular Assist Device(day 30, Day 60, Day180)
- Cumulated amount of administered fluids(up to 180 days (from date of randomization until ECMO weaning))
- Cumulated amount of vasopressors use(up to 180 days (from date of randomization until ECMO weaning))
- Infection(Hour 48, Day 7, Day 30, Day 60, day 180)
- hospitalization stay(Day 30; Day 60; Day 180)
- bleeding complications(Hour 48, Day 7)
研究者
研究点 (20)
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