Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial.

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.

• Authors: Peter J Kudenchuk, Siobhan P Brown, Mohamud Daya, Laurie J Morrison, Brian E Grunau, Tom Rea, Tom Aufderheide, Judy Powell, Brian Leroux, Christian Vaillancourt, Jonathan Larsen, Lynn Wittwer, M Riccardo Colella, Shannon W Stephens, Mark Gamber, Debra Egan, Paul Dorian, Resuscitation Outcomes Consortium Investigators
• Journal: American heart journal (Am Heart J) Vol. 167 Issue 5 Pg. 653-9.e4 (May 2014) ISSN: 1097-6744 [Electronic] United States
• PMID: 24766974 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
• Copyright: Copyright © 2014 Mosby, Inc. All rights reserved.

Chemical References

• Anti-Arrhythmia Agents
• Lidocaine
• Amiodarone

Topics

• Adolescent
• Adult
• Amiodarone (administration & dosage)
• Anti-Arrhythmia Agents (administration & dosage)
• Cardiopulmonary Resuscitation (methods)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Emergency Medical Services
• Female
• Follow-Up Studies
• Heart Rate (drug effects)
• Humans
• Lidocaine (administration & dosage)
• Male
• North America (epidemiology)
• Out-of-Hospital Cardiac Arrest (etiology, mortality, therapy)
• Prospective Studies
• Treatment Outcome
• Ventricular Fibrillation (complications, drug therapy, mortality)
• Young Adult