UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Time to death from any-cause within 30 days after randomization
研究概览
简要总结
Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.
详细描述
In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .
The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe cardiogenic shock due to severe left ventricular dysfunction:
- •Systolic blood pressure <90 mmHg or need for catecholamines to maintain such blood pressure
- •Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output <30 ml/h
- •Arterial lactate >5 mmol/l
排除标准
- •Post-cardiotomy cardiogenic shock.
- •Cardiogenic shock due to acute rejection in heart transplant recipients.
- •Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism)
- •Cardiogenic shock due to other causes (e.g. bleeding, hypothermia)
- •Pre-existing Impella treatment.
- •Onset of shock >12 hours.
- •Mechanical complication of acute myocardial infarction.
- •Prolonged resuscitation (>60 minutes).
- •Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation.
- •Age <18 or >80 years.
- •Other severe concomitant disease with life expectancy <6 months.
- •Participation in another trial with an intervention or pregnancy.
研究组 & 干预措施
Impella + VA-ECMO
干预措施: Impella (Device)
Impella + VA-ECMO
干预措施: VA-ECMO (Device)
VA-ECMO only
干预措施: VA-ECMO (Device)
结局指标
主要结局
Time to death from any-cause within 30 days after randomization
时间窗: 30 days
Time to death from any-cause within 30 days after randomization
次要结局
- Death from any-cause at 6 and 12 months as well as time to death at these time points(6 and 12 months)
- Cardiovascular death at day 30, 6 months and 12 months as well as time to death at these time points(30 days, 6 and 12 months)
- Length of veno-arterial extracorporeal membrane oxygenation therapy, mechanical ventilation, inotrope therapy and stay at the intensive care unit (in days).(12 months)
- Days free from veno-arterial extracorporeal membrane oxygenation therapy in 30 days(30 days)
- Need for renal replacement therapy until day 30, 6 months and 12 months(30 days, 6 and 12 months)
- Neurological function (per Cerebral Performance Category) at day 30, 6 months and 12 months(30 days, 6 and 12 months)
- Rate of incidence of hospitalization for heart failure (hospitalization for more than 24 hours with heart failure as the main reason) as well as time to first event after 6 months and 12 months and recurrent events within 12 months(6 and 12 months)
- Left ventricular function assessed by echocardiography at day 30, 6 months and 12 months(30 days, 6 and 12 months)
- Quality of life as assessed by the "Kansas City Cardiomyopathy Questionnaire" at 30-days and at 12 months(30 days and 6 months)
- 6-Minute Walking Distance at day 30, 6 months and 12 months(30 days, 6 and 12 months)