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Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest: Design and rationale of the INCEPTION trial.
- Source :
-
American heart journal [Am Heart J] 2019 Apr; Vol. 210, pp. 58-68. Date of Electronic Publication: 2018 Dec 14. - Publication Year :
- 2019
-
Abstract
- 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.<br />Hypothesis: We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status.<br />Study Design: 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.<br />Summary: 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.<br /> (Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Blood Circulation
Defibrillators
Emergency Medical Services
Humans
Intention to Treat Analysis
Middle Aged
Neurologic Examination
Out-of-Hospital Cardiac Arrest mortality
Prospective Studies
Survival Rate
Tachycardia therapy
Time Factors
Ventricular Fibrillation therapy
Cardiopulmonary Resuscitation methods
Extracorporeal Membrane Oxygenation
Multicenter Studies as Topic
Out-of-Hospital Cardiac Arrest therapy
Randomized Controlled Trials as Topic
Time-to-Treatment
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 210
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 30738245
- Full Text :
- https://doi.org/10.1016/j.ahj.2018.12.008