NCT03101787

Early Initiation of Extracorporeal Life Support in Refractory OHCA

Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiac Arrest
• Out-Of-Hospital Cardiac Arrest
• Sudden Cardiac Death

Interventions

Type	Name	Description
PROCEDURE	Extracorporeal cardiopulmonary resuscitation (ECPR)	In addition to the routine response team, the ECLS team are called to the ED while the patient is transported to the hospital. The team consists of a physician skilled and qualified in femoral cannulation, a perfusionist and a scrub nurse. Upon the patient's arrival at the emergency department, CPR will be continued, with continuation of mechanical chest compressions with minimization of interruptions. Time from arrest to start of cannulation is \< 60 minutes.

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-02-10
• Completion: 2022-02-10
• First posted: 2017-04-05
• Last updated: 2022-10-18

Locations

10 sites across 1 country: Netherlands