NCT03740711已完成不适用
Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- weaning rate of VA-ECMO
研究概览
简要总结
The EVOLVE-ECMO(Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation Support) study is a randomized controlled trial to evaluate the prognostic effect of early LA venting(when detect B-line on serial lung ultrasound) on weaning VA-ECMO support in refractory CS who receive VA-ECMO support. The aim of EVOLVE-ECMO trial is to test the hypothesis that early LA venting would result in a significant reduction in failure of weaning ECMO support in refractory CS.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was > 18 years of age.
- •Subjects who underwent successful VA-ECMO support
- •Subjects with refractory cardiogenic shock who had pulmonary edema confirmed by chest X ray or lung sonogram.
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •subject was <80 years of age
- •Pregnant and/or lactate women
- •Subjects who underwent VA-ECMO after recent open heart surgery
- •Subjects who underwent VA-ECMO after non-cardiogenic arrest(trauma, hypothermia, submersion, drug overdose, asphyxia, intracranial hemorrhage etc)
- •Severe bleeding tendency
- •Terminal malignancy
- •Known severe irreversible brain damage
- •Subject was unable to provide written informed consent or participate.
结局指标
主要结局
weaning rate of VA-ECMO
时间窗: during index admission
Weaning of VA-ECMO support
次要结局
- Success rate to heart transplantation(during index admission)
- In hospital mortality(during index admission)
- Adverse outcome due to LA venting(during index admission)
- Free days for mechanical ventilation(during index admission)
- rate of improving for pulmonary edema(during index admission)
研究者
Min-Seok Kim
Clinical assistant professor
Asan Medical Center
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Early Left Atrial Venting Versus Conventional Treatment For Left VEntricular Decompression During Venoarterial ExtraCorporeal Membrane Oxygenation SupportKCT0003272Asan Medical Center60
已完成
不适用
Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane OxygenationCardiogenic ShockNCT04775472Chonnam National University Hospital116
已完成
不适用
To assess the efficacy of Echocardiographic parameter and carotid artery ultrasonosonography parameter to predict which patient need intravenous fluid in ICCTRI/2017/11/010434AIIMS60
终止
不适用
Impella CP With VA ECMO for Cardiogenic ShockCardiogenic ShockNCT03431467University of Pennsylvania17
Unknown
不适用
Atrioventricular Optimization for Dual Chamber PacemakerAV BlockNCT03556189Yong Seog Oh70