Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 10
- 主要终点
- 30-day survival rate with favorable neurological status
研究概览
简要总结
Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.
详细描述
There are approximately 275,000 cases of out-of-hospital cardiac arrest (OHCA) per year in Europe, of which two-thirds have a primary cardiac origin. However, despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of these patients fail to achieve sustained return of spontaneous circulation (ROSC).
Treatment of the underlying cause of the arrest, in most cases coronary artery occlusion, is paramount. But in the absence of ROSC, the possibilities to perform these life-saving interventions are limited. Continued CCPR is currently the standard of care for these patients. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) restores circulation, with the potential to minimize (or even reversing) organ damage, prevent re-arrest due to ischemia-triggered myocardial dysfunction and providing a bridge to possible diagnosis and treatment. Several studies have demonstrated that ECPR is feasible and may be advantageous with respect to survival and neurological outcome.
The INCEPTION trial aims to compare ECPR to CCPR in the population that is expected to benefit the most from this intervention: young patients presenting with ventricular fibrillation or tachycardia (VF/VT) and a refractory cardiac arrest. Furthermore, it will provide data on the cost-effectiveness of this intervention, which to date has been unavailable. Although the costs may prove to be high, the gain in quality-adjusted life years (QALY's) may be substantial given the fact that most patients are relatively young and the current alternative carries a poor prognosis. This can determine whether ECPR should be pursued as a standard of care in patients with refractory arrest.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 - ≤70 years
- •Witnessed OHCA (by bystanders)
- •Initial rhythm of VF/VT or AED administered
- •Bystander BLS
排除标准
- •ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery
- •Terminal heart failure (NYHA III or IV)
- •Severe pulmonary disease (COPD GIII of GIV)
- •Disseminated oncological disease
- •Obvious or suspected pregnancy
- •Bilateral femoral bypass surgery
- •Known contraindications for ECPR
- •Known pre-arrest CPC-score of 3 or 4
- •Known limitations in therapy or a Do Not Resuscitate-order
- •Multitrauma (Injury Severity Score >15)
- •Expected time-to-start cannulation > 60 minutes
研究组 & 干预措施
CCPR protocol
Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and rapid transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).
Clinical Upon the patient's arrival, the standard of care (CCPR) will be continued according to ERC guidelines.
No special preparations for the trial are needed before the patient's arrival.
ECPR protocol
Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).
Clinical The ECPR team is mobilized while the patient is transported to the hospital. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Time from arrest to start of cannulation is < 60 minutes.
干预措施: Extracorporeal cardiopulmonary resuscitation (ECPR) (Procedure)
结局指标
主要结局
30-day survival rate with favorable neurological status
时间窗: 30 days
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale
次要结局
- Costs per gained QALY for ECPR vs. CCPR(1 year)
- Length of stay at the ICU(1 year)
- Neurological outcome on the CPC scale(30 days, 3 months, 6 months and 12 months)
- Quality Adjusted Life Years (QALY's)(30 days, 3 months, 6 months and 12 months)
- Reason for discontinuation of treatment between the treatment groups(Within 1 year)
- Time to return of circulation(Within 1 year)
- Additional costs of ECPR with respect to CCPR(1 year)
- Length of stay at the hospital(1 year)
- Duration of clinical rehabilitation time(1 year)
- Duration of mechanical ventilation(1 year)
- Need for renal replacement therapy(1 year)
- Acute kidney injury according to the RIFLE criteria(1 year)
- Time to target hypothermia(1 year)
- Difference in metabolic markers between treatment groups(6 days)
- Difference in metabolic markers between between the survivors and non-survivors(6 days)