Resuscitation outcomes consortium-amiodarone, lidocaine or placebo study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial

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

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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.

Original languageEnglish (US)
Pages (from-to)653-659.e4
JournalAmerican heart journal
Volume167
Issue number5
DOIs
StatePublished - May 2014

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Kudenchuk, P. J., Brown, S. P., Daya, M., Morrison, L. J., Grunau, B. E., Rea, T., Aufderheide, T., Powell, J., Leroux, B., Vaillancourt, C., Larsen, J., Wittwer, L., Colella, M. R., Stephens, S. W., Gamber, M., Egan, D., & Dorian, P. (2014). Resuscitation outcomes consortium-amiodarone, lidocaine or placebo study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial. American heart journal, 167(5), 653-659.e4. https://doi.org/10.1016/j.ahj.2014.02.010