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 Resuscitation Outcomes Consortium Amiodarone, Lidocaine, or Placebo Study (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 3000 adults across North America with non-traumatic 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. ALPS’ primary outcome is survival to hospital discharge; a secondary outcome is functional survival at discharge assessed as a Modified Rankin Score ≤3. Results ALPS’ principal aim is to determine if survival is improved by amiodarone compared to placebo; secondary aims are to determine if survival is improved by lidocaine versus placebo, and/or by amiodarone versus 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.

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest

“…9 All comparisons in this report, including testing interactions, were recalculated as two-sided with P values of less than or equal to 0.05 considered to indicate statistical significance (as most comparisons were initially performed), which did not substantially change the results.…”

“…9 Paramedics from 55 emergency medical services (EMS) agencies enrolled patients with out-of-hospital cardiac arrest at 10 North American sites participating in the Resuscitation Outcomes Consortium (ROC). 10 The trial was conducted under exception from informed consent in emergency research in accordance with applicable regulatory requirements, oversight by the Food and Drug Administration and Health Canada, approval by institutional review boards in participating communities, and monitoring by an independent data and safety monitoring board appointed by the National Heart, Lung, and Blood Institute (NHLBI).…”

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“…There were no differences in outcomes across the 3 groups. Finally, data from the Resuscitation Outcomes Consortium ALPS examined the association between antiarrhythmic use and rearrest or quantitative ECG waveform characteristics 2, 7. The use of antiarrhythmics (amiodarone, lidocaine, or placebo) did not affect rearrest rates.…”

“…Researchers also presented the results of examining hypoxia and hyperoxia in resuscitated patients from the CRITICA (Comprehensive Registry of In‐Hospital Care for OHCA Survival) study from Osaka, Japan 7, 8. In another abstract presentation, the Get With the Guidelines‐Resuscitation (http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines-Resuscitation/Get-With-The-Guidelines-Resuscitation_UCM_314496_SubHomePage.jsp) database was used to derive and validate a score to predict outcomes in pediatric patients resuscitated from cardiac arrest.…”

Sudden cardiac death in the young

“…4 The Resuscitation Outcomes Consortium is currently conducting a study of antiarrhythmic use during CPR. 203 High Quality CPR-It has become apparent that high quality CPR is a major determinant of survival. 4,160,184,204,205 In practice, CPR performance is often sub-optimal by both EMS and hospital providers.…”