Rationale and methods of the Advanced R2Eperfusion STrategies for Refractory Cardiac Arrest (ARREST) trial.
Am Heart J
; 229: 29-39, 2020 11.
Article
in En
| MEDLINE
| ID: mdl-32911433
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 <30â¯minutes.SETTING:
Hospital-based.OUTCOMES:
Primary survival to hospital discharge. Secondary safety, survival, and functional assessment at hospital discharge and 3 and 6â¯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 Nâ¯=â¯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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ventricular Fibrillation
/
Extracorporeal Membrane Oxygenation
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Cardiopulmonary Resuscitation
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Out-of-Hospital Cardiac Arrest
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Percutaneous Coronary Intervention
Type of study:
Clinical_trials
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Diagnostic_studies
/
Etiology_studies
/
Guideline
Limits:
Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Am Heart J
Year:
2020
Document type:
Article
Publication country:
EEUU
/
ESTADOS UNIDOS
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ESTADOS UNIDOS DA AMERICA
/
EUA
/
UNITED STATES
/
UNITED STATES OF AMERICA
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US
/
USA