Early Left Atrial Venting Versus Conventional Treatment For Left Ventricular Decompression During Venoarterial Extracorporeal Membrane Oxygenation Support (EVOLVE-ECMO Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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.
研究组 & 干预措施
Early LA venting
When detect B-line on serial lung ultrasound, we will perform early LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support.
干预措施: Left atrial venting (Procedure)
Conventional LA venting
When detect refractory pulmonary congestion on chest radiograph or inadequate AV opening on serial echocardiography, we will perform LA venting for improving LV distention in patients with refractory cardiogenic shock who received VA-ECMO support.
干预措施: Left atrial venting (Procedure)
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
- rate of improving for pulmonary edema(during index admission)
- 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)
研究者
Min-Seok Kim
Clinical assistant professor
Asan Medical Center