Faculty Collaboration Database

Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial. Am Heart J 2014 May;167(5):653-9.e4

Date

04/29/2014

Pubmed ID

24766974

Pubmed Central ID

PMC4014351

DOI

10.1016/j.ahj.2014.02.010

Scopus ID

2-s2.0-84899495190 (requires institutional sign-in at Scopus site)   52 Citations

Abstract

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.

Author List

Kudenchuk PJ, Brown SP, Daya M, Morrison LJ, Grunau BE, Rea T, Aufderheide T, Powell J, Leroux B, Vaillancourt C, Larsen J, Wittwer L, Colella MR, Stephens SW, Gamber M, Egan D, Dorian P, Resuscitation Outcomes Consortium Investigators

Authors

Tom P. Aufderheide MD Professor in the Emergency Medicine department at Medical College of Wisconsin
Walter Biakowski in the CTSI department at Medical College of Wisconsin - CTSI
Mario R. Colella DO, MPH Professor in the Emergency Medicine department at Medical College of Wisconsin
Olga Y. Kaslow MD, PhD Professor in the Anesthesiology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Amiodarone
Anti-Arrhythmia Agents
Cardiopulmonary Resuscitation
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Emergency Medical Services
Female
Follow-Up Studies
Heart Rate
Humans
Lidocaine
Male
North America
Out-of-Hospital Cardiac Arrest
Prospective Studies
Treatment Outcome
Ventricular Fibrillation
Young Adult