Abstract | BACKGROUND: 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.
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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.)
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Copyright | Copyright © 2014 Mosby, Inc. All rights reserved. |
Chemical References |
- Anti-Arrhythmia Agents
- Lidocaine
- Amiodarone
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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
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