NCT03637205已完成不适用
Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 46
- 主要终点
- 30-day mortality
研究概览
简要总结
The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:
- •Planned revascularization (PCI or alternatively CABG)
- •Systolic blood pressure <90 mmHg >30 min or catecholamines required to maintain pressure >90 mmHg during Systole
- •Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output <30 ml/h
- •Arterial lactate >3 mmol/l
- •Informed consent
排除标准
- •Resuscitation >45 minutes
- •Mechanical cause of cardiogenic shock
- •Onset of shock >12 h
- •Severe peripheral artery disease with impossibility to insert ECLS cannulae
- •Age <18 years or age >75 years
- •Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
- •Other severe concomitant disease with limited life expectancy <6 months
- •Pregnancy
- •Participation in another trial
研究组 & 干预措施
ECLS
Experimental
PCI (or CABG) plus medical treatment + ECLS
干预措施: ECLS insertion (Procedure)
ECLS
Experimental
PCI (or CABG) plus medical treatment + ECLS
干预措施: Revascularisation and optimal medical treatment (Other)
No ECLS
Active Comparator
PCI (or CABG) plus medical treatment
干预措施: Revascularisation and optimal medical treatment (Other)
结局指标
主要结局
30-day mortality
时间窗: 30 days
30-day all-cause death after randomization according to the intention-to-treat principle
次要结局
- Serial SAPS-II score(0 to 11 days)
- Length of ICU stay(0 to 11 days)
- Length of hospital stay(0 to 14 days)
- Acute renal failure requiring renal replacement therapy(0 to 14 days)
- Hospitalization for heart failure(6 and 12 months)
- Time to hemodynamic stabilization(0 to 10 days)
- Length of mechanical ventilation(0 to 10 days)
- Cerebral performance category (CPC)(30 days, 6 and 12 months)
- Recurrent infarction(30 days, 6 and 12 months)
- Repeat revascularization (PCI or CABG)(30 days, 6 and 12 months)
- Mean and area under the curve of arterial lactate(0 to 14 days)
- Time to death within 6 and 12 months follow-up(6 and 12 months)
- Serial creatinine-level and creatinine-clearance(0 to 10 days from time of randomization until stabilization)
- Status of Quality of life measured by EQ VAS(12 months)
- Duration of catecholamine therapy(0 to 10 days)
- Cardiovascular mortality(6 and 12 months)
- Status of Quality of life measured by EQ-5D-5L descriptive system(12 months)
研究者
研究点 (46)
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