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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.AH

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+Show Affiliations

Department of Medicine, Division of Cardiology, University of Washington, Seattle, WA; Public Health-Seattle & King County, Seattle, WA. Electronic address: kudenchuk@u.washington.edu.Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.Department of Emergency Medicine, Oregon Health & Science University, Portland, OR.RESCU, Keenan Research Centre, St Michael's Hospital, Division of Emergency Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.Public Health-Seattle & King County, Seattle, WA; Department of Medicine, University of Washington, Seattle, WA.Medical College of Wisconsin, Milwaukee, WI.Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.Department of Biostatistics, Clinical Trial Center, University of Washington, Seattle, WA.Department of Emergency Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.Seattle Fire Department, Seattle, WA.Peace Health Southwest Medical Center, Vancouver, WA.Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee WI.Department of Emergency Medicine, University of Alabama, Birmingham, AL.Plano Fire Rescue, Plano, TX.National Heart Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.Department of Medicine, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.No affiliation info available

Pub Type(s)

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.

Language

eng

PubMed ID

24766974

Citation

Kudenchuk, Peter J., et al. "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, vol. 167, no. 5, 2014, pp. 653-9.e4.
Kudenchuk PJ, Brown SP, Daya M, et al. 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;167(5):653-9.e4.
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-e4. https://doi.org/10.1016/j.ahj.2014.02.010
Kudenchuk PJ, et al. 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;167(5):653-9.e4. PubMed PMID: 24766974.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial. AU - Kudenchuk,Peter J, AU - Brown,Siobhan P, AU - Daya,Mohamud, AU - Morrison,Laurie J, AU - Grunau,Brian E, AU - Rea,Tom, AU - Aufderheide,Tom, AU - Powell,Judy, AU - Leroux,Brian, AU - Vaillancourt,Christian, AU - Larsen,Jonathan, AU - Wittwer,Lynn, AU - Colella,M Riccardo, AU - Stephens,Shannon W, AU - Gamber,Mark, AU - Egan,Debra, AU - Dorian,Paul, AU - ,, Y1 - 2014/03/01/ PY - 2013/12/16/received PY - 2014/02/05/accepted PY - 2014/4/29/entrez PY - 2014/4/29/pubmed PY - 2014/6/18/medline SP - 653 EP - 9.e4 JF - American heart journal JO - Am. Heart J. VL - 167 IS - 5 N2 - 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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/24766974/Resuscitation_Outcomes_Consortium_Amiodarone_Lidocaine_or_Placebo_Study__ROC_ALPS_:_Rationale_and_methodology_behind_an_out_of_hospital_cardiac_arrest_antiarrhythmic_drug_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(14)00093-3 DB - PRIME DP - Unbound Medicine ER -