Martine E Bol1, Martje M Suverein2, Roberto Lorusso3, Thijs S R Delnoij4, George J Brandon Bravo Bruinsma5, Luuk Otterspoor6, Marijn Kuijpers7, Ka Yan Lam8, Alexander P J Vlaar9, Carlos V Elzo Kraemer10, Joris J van der Heijden11, Erik Scholten12, Antoine H G Driessen13, José M Montero Cabezas14, Saskia Z H Rittersma15, Bram G Heijnen12, Fabio S Taccone16, Brigitte Essers17, Tammo Delhaas18, Patrick W Weerwind19, Paul M H J Roekaerts20, Jos G Maessen19, Marcel C G van de Poll21. 1. 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. 2. Department of Intensive Care, Maastricht University Medical Center, Maastricht, The Netherlands; CARIM, School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands. Electronic address: martje.suverein@mumc.nl. 3. Department of Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. 4. Department of Intensive Care, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands. 5. Department of Cardiothoracic Surgery, Isala Klinieken, Zwolle, The Netherlands. 6. Department of Intensive Care, Catharina Hospital, Eindhoven, The Netherlands. 7. Department of Intensive Care, Isala Klinieken, Zwolle, The Netherlands. 8. Department of Cardiothoracic Surgery, Catharina Hospital, Eindhoven, The Netherlands. 9. Department of Intensive Care, Amsterdam University Medical Center location AMC, Amsterdam, The Netherlands. 10. Department of Intensive Care, Leiden University Medical Center, Leiden, The Netherlands. 11. Department of Intensive Care, University Medical Center Utrecht, Utrecht, The Netherlands. 12. Department of Intensive Care, St. Antonius Hospital, Nieuwegein, The Netherlands. 13. Heart Center, Department of Cardiothoracic Surgery, Amsterdam University Medical Center location AMC, Amsterdam, The Netherlands. 14. Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. 15. Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. 16. Department of Intensive Care, Université Libre de Bruxelles, Hôpital Erasme Bruxelles, Brussels, Belgium. 17. Department of Clinical Epidemiology and Medical Technical Assessment, Maastricht University Medical Center, Maastricht, The Netherlands. 18. CARIM, School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands; Department of Biomedical Engineering, Maastricht University, Maastricht, The Netherlands. 19. CARIM, School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands; Department of Cardiothoracic Surgery, Maastricht University Medical Center, Maastricht, The Netherlands. 20. Department of Intensive Care, Maastricht University Medical Center, Maastricht, The Netherlands; CARIM, School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands. 21. 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 Surgery, Maastricht University Medical Center, Maastricht, The Netherlands.
Abstract
Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoingcardiopulmonary 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. HYPOTHESIS: We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status. 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. 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.
RCT Entities:
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. HYPOTHESIS: We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status. 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. 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.
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