Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial.
BACKGROUND
Despite their wide use, whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest (OHCA) is not known. The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (VF/VT).


METHODS
ALPS will randomize 3,000 adults across North America with nontraumatic OHCA, persistent or recurring VF/VT after ≥1 shock, and established vascular access to receive up to 450 mg amiodarone, 180 mg lidocaine, or placebo in the field using a double-blind protocol, along with standard resuscitation measures. The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT. A safety analysis includes all randomized patients regardless of their eligibility, initial arrhythmia, or actual receipt of ALPS drug. The primary outcome of ALPS is survival to hospital discharge; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score ≤3.


RESULTS
The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine. Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge. Each aim also represents a clinically relevant comparison between treatments that is worth investigating.


CONCLUSIONS
Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice.
Department of Medicine, Division of Cardiology, University of Washington, Seattle, WA; Public Health-Seattle & King County, Seattle, WA. Electronic address: kudenchuk@u.washington.edu.
Peter J
PJ
Kudenchuk
Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.
Siobhan P
SP
Brown
Department of Emergency Medicine, Oregon Health & Science University, Portland, OR.
Mohamud
M
Daya
RESCU, Keenan Research Centre, St Michael's Hospital, Division of Emergency Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Laurie J
LJ
Morrison
Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Brian E
BE
Grunau
Public Health-Seattle & King County, Seattle, WA; Department of Medicine, University of Washington, Seattle, WA.
Tom
T
Rea
Medical College of Wisconsin, Milwaukee, WI.
Tom
T
Aufderheide
Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.
Judy
J
Powell
Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.
Brian
B
Leroux
Department of Emergency Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.
Christian
C
Vaillancourt
Seattle Fire Department, Seattle, WA.
Jonathan
J
Larsen
Peace Health Southwest Medical Center, Vancouver, WA.
Lynn
L
Wittwer
Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee WI.
M Riccardo
MR
Colella
Department of Emergency Medicine, University of Alabama, Birmingham, AL.
Shannon W
SW
Stephens
Plano Fire Rescue, Plano, TX.
Mark
M
Gamber
National Heart Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.
Debra
D
Egan
Department of Medicine, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Paul
P
Dorian
D000293:Adolescent; D000328:Adult; D000638:Amiodarone / Q000008:administration & dosage*; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage; D016887:Cardiopulmonary Resuscitation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004632:Emergency Medical Services; D005260:Female; D005500:Follow-Up Studies; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D009656:North America / Q000453:epidemiology; D058687:Out-of-Hospital Cardiac Arrest / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D055815:Young Adult
D000889:Anti-Arrhythmia Agents; D008012:Lidocaine; D000638:Amiodarone