Abstract
BACKGROUND: Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown.
AIM: The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation.
DESIGN: Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial.
POPULATION: Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes.
SETTING: Hospital-based.
OUTCOMES: Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost.
SAMPLE SIZE: Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
CONCLUSIONS: The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 29-39 |
| Number of pages | 11 |
| Journal | American Heart Journal |
| Volume | 229 |
| DOIs | |
| State | Published - Nov 2020 |
Bibliographical note
Funding Information:Funding: This clinical trial is supported by National Institutes of Health grants 4R33HL142696-02 and 1R61HL142696-01, both of which were awarded to Dr Demetris Yannopoulos.The ARREST trial is funded by the National Heart, Lung, and Blood Institute. This study qualifies for and will be performed using Waiver from Informed Consent Requirements for Emergency Research under Federal Regulation 21 CFR 50.24. An investigational device exemption was acquired from the United States Food and Drug Administration (IDE-G180285/A001) for longer use of ECMO than the currently labeled 6-hour time period. The trial protocol was registered at clinicaltrials.gov (NCT 038805365). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Funding Information:
Funding: This clinical trial is supported by National Institutes of Health grants 4R33HL142696-02 and 1R61HL142696-01 , both of which were awarded to Dr Demetris Yannopoulos.
Publisher Copyright:
© 2020 The Authors
Keywords
- Cardiopulmonary Resuscitation/methods
- Extracorporeal Membrane Oxygenation/methods
- Female
- Functional Status
- Humans
- Intention to Treat Analysis
- Male
- Middle Aged
- Out-of-Hospital Cardiac Arrest/etiology
- Patient Discharge/statistics & numerical data
- Percutaneous Coronary Intervention/methods
- Survival Analysis
- Treatment Outcome
- Ventricular Fibrillation/complications
PubMed: MeSH publication types
- Randomized Controlled Trial
- Clinical Trial, Phase II
- Journal Article
- Research Support, N.I.H., Extramural