Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Przeglądasz jako GOŚĆ
Tytuł pozycji:

Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.

Tytuł :
Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.
Autorzy :
Yannopoulos D; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA. Electronic address: .
Bartos J; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Raveendran G; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Walser E; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Connett J; Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Murray TA; Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Collins G; Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Zhang L; Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Kalra R; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Kosmopoulos M; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
John R; Division of Cardiothoracic Surgery, Department of Surgery, University of Minnesota Medical School, Minneapolis, MN, USA.
Shaffer A; Division of Cardiothoracic Surgery, Department of Surgery, University of Minnesota Medical School, Minneapolis, MN, USA.
Frascone RJ; St Paul Fire and Emergency Medical Services, St Paul, MN, USA.
Wesley K; M Health Fairview Emergency Medical Services, Minneapolis, MN, USA.
Conterato M; North Memorial Emergency Medical Services, Robbinsdale, MN, USA.
Biros M; Department of Emergency Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Tolar J; Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Aufderheide TP; Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
Pokaż więcej
Źródło :
Lancet (London, England) [Lancet] 2020 Dec 05; Vol. 396 (10265), pp. 1807-1816. Date of Electronic Publication: 2020 Nov 13.
Typ publikacji :
Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
Język :
English
Imprint Name(s) :
Publication: 2004- : London : Elsevier
Original Publication: London : J. Onwhyn
MeSH Terms :
Advanced Cardiac Life Support/*methods
Extracorporeal Membrane Oxygenation/*methods
Out-of-Hospital Cardiac Arrest/*therapy
Reperfusion/*methods
Ventricular Fibrillation/*diagnosis
Adult ; Advanced Cardiac Life Support/standards ; Aged ; Cardiopulmonary Resuscitation/methods ; Female ; Humans ; Male ; Middle Aged ; Out-of-Hospital Cardiac Arrest/epidemiology ; Outcome Assessment, Health Care ; Patient Discharge/trends ; Safety ; Survival ; Time Factors ; Treatment Outcome ; Ventricular Fibrillation/complications ; Ventricular Fibrillation/physiopathology ; Young Adult
References :
Circulation. 2016 Apr 5;133(14):1386-96. (PMID: 26920493)
Eur Heart J Acute Cardiovasc Care. 2014 Jun;3(2):183-91. (PMID: 24569450)
Circulation. 2019 Mar 19;139(12):e530-e552. (PMID: 30760026)
Am Heart J. 2020 Nov;229:29-39. (PMID: 32911433)
EClinicalMedicine. 2020 Nov 13;29-30:100632. (PMID: 33437949)
Eur Heart J. 2020 Jun 1;41(21):1961-1971. (PMID: 31670793)
J Am Heart Assoc. 2016 Jun 13;5(6):. (PMID: 27412906)
Resuscitation. 2018 May;126:154-159. (PMID: 29253646)
J Am Coll Cardiol. 2017 Aug 29;70(9):1109-1117. (PMID: 28838358)
Resuscitation. 2018 Nov;132:47-55. (PMID: 30171974)
Circulation. 2020 Mar 17;141(11):877-886. (PMID: 31896278)
Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. (PMID: 26472995)
Prehosp Emerg Care. 2016 Sep-Oct;20(5):615-22. (PMID: 27018764)
Circulation. 2019 Dec 10;140(24):e881-e894. (PMID: 31722552)
Circulation. 2019 Aug 27;140(9):e517-e542. (PMID: 31291775)
Intensive Care Med. 2018 Dec;44(12):2153-2161. (PMID: 30430207)
Resuscitation. 2016 Apr;101:50-6. (PMID: 26851705)
Circulation. 2019 Dec 10;140(24):e895-e903. (PMID: 31722563)
Grant Information :
R33 HL142696 United States HL NHLBI NIH HHS; R61 HL142696 United States HL NHLBI NIH HHS
Molecular Sequence :
ClinicalTrials.gov NCT03880565
Entry Date(s) :
Date Created: 20201116 Date Completed: 20210326 Latest Revision: 20210716
Update Code :
20210716
PubMed Central ID :
PMC7856571
DOI :
10.1016/S0140-6736(20)32338-2
PMID :
33197396
Czasopismo naukowe
Background: Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation.
Methods: For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18-75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565.
Findings: Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36-73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed.
Interpretation: Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment.
Funding: National Heart, Lung, and Blood Institute.
(Copyright © 2020 Elsevier Ltd. All rights reserved.)
Comment in: Lancet. 2021 Jul 3;398(10294):22-23. (PMID: 34217390)

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies