Early Intra-aortic Balloon Pump Use After Venoarterial Extracorporeal Membrane Oxygenation: The EASE-ECMO Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- 30-day mortality
研究概览
简要总结
The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is :
• If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.
详细描述
The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.
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 (Participant, Care Provider, Outcomes Assessor)
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
- •Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion)
- •Successful implantation of VA-ECMO
- •Informed consent
排除标准
- •SCAI shock stage A or B
- •Presence of moderate to severe aortic insufficiency or aortic dissection
- •Severe peripheral vascular disease
- •Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD).
- •VA-ECMO for definite non-cardiac causes
- •Isolated right ventricular failure
- •V-A ECMO usage confined to the period during surgery or other interventions
- •Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture)
- •Extracorporeal cardiopulmonary resuscitation
- •LVAD, Impella or IABP in situ.
- •Severe bleeding
- •Terminal malignancy
- •Irreversible neurologic injury
- •Pregnancy or lactation
研究组 & 干预措施
ECMO+IABP group
Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
干预措施: Early IABP use (Other)
ECMO group
Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.
干预措施: Conventional approach (Other)
结局指标
主要结局
30-day mortality
时间窗: 30 days
次要结局
- Rate of advanced mechanical unloading(30 days)
- In-hospital Mortality(30 days)
- weaning from VA-ECMO(30 days)
- Left Ventricular Function of survivors(30 days)
- Day of Mechanical Circulatory Support Device Weaning(30 days)
- Rate of pulmonary congestion on chest X-ray(30 days)
- Reduction in Myocardial Injury Biomarkers (cTnI/cTnT)(30 days)
- Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP)(30 days)
- ICU length of stay(30 days)
- Hospital length of stay(30 days)
- Duration of VA-ECMO(30 days)
- Lactate clearance rate at 12 and 24 hours(30 days)
- Rate of CRRT(30 days)
- Rate of ventricular arrhythmia(30 days)
- Rate of bleeding(30 days)
- Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours(30 days)
- Rate of stroke(30 days)
- Rate of limb ischemia(30 days)
- Duration of mechanical ventilation(30 days)
- Rate of infection(30 days)
研究者
Xiaotong Hou
Professor
Beijing Anzhen Hospital