Department of Intensive Care, Maastricht University Medical Center, Maastricht, The Netherlands; NUTRIM, School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.
Department of Intensive Care, Maastricht University Medical Center, Maastricht, The Netherlands; CARIM, School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands.
Am Heart J. 2019 Apr;210:58-68. doi: 10.1016/j.ahj.2018.12.008. Epub 2018 Dec 14.
Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR.
We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status.
The INCEPTION trial is an investigator-initiated, prospective, multicenter trial that will randomly allocate 110 patients to either continued CPR or ECPR in a 1:1 ratio. Patients eligible for inclusion are adults (≤ 70 years) with witnessed OHCA presenting with an initial rhythm of ventricular fibrillation (VF) or ventricular tachycardia (VT), who received bystander basic life support and who fail to achieve sustained return of spontaneous circulation within 15 minutes of cardiopulmonary resuscitation by emergency medical services. The primary endpoint of the study is 30-day survival rate with favorable neurological status, defined as 1 or 2 on the Cerebral Performance Category score. The secondary endpoints include 3, 6 and 12-month survival rate with favorable neurological status and the cost-effectiveness of ECPR compared to CCPR.
The INCEPTION trial aims to determine the clinical benefit for the use of ECPR in patients with refractory OHCA presenting with VF/VT. Additionally, the feasibility and cost-effectiveness of ECPR will be evaluated.
本研究旨在评估早期实施体外心肺复苏（ECPR）对改善难治性院外心脏骤停（OHCA）患者存活率和神经功能预后的效果。
INCEPTION 试验是一项由研究者发起的、前瞻性的、多中心临床试验，将按照 1:1 的比例将 110 例符合条件的患者随机分配至继续行心肺复苏（CPR）或早期行 ECPR。纳入标准为：年龄≤70 岁、目击 OHCA 发作、初始节律为室颤（VF）或室性心动过速（VT）、接受过旁观者基本生命支持且在 15 分钟内未能通过急救医疗服务实现自主循环持续恢复的成年患者。该研究的主要终点为 30 天存活率和良好的神经功能预后（定义为改良脑功能预后评分 1 或 2 分）。次要终点包括 3、6 和 12 个月的存活率和神经功能预后、以及与 CCPR 相比 ECPR 的成本效益。
INCEPTION 试验旨在确定 ECPR 在治疗难治性 OHCA 伴 VF/VT 患者中的临床应用价值。此外，还将评估 ECPR 的可行性和成本效益。
