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

详细信息    查看全文

• 作者：Peter J. Kudenchuk ; MD^a ; ^b ; ^{kudenchuk@u.washington.edu" class="auth_mail} ; Siobhan P. Brown ; PhD^c ; Mohamud Daya ; MD^d ; Laurie J. Morrison ; MSc ; MD^e ; Brian E. Grunau ; MD^f ; Tom Rea ; MD^b ; ^g ; Tom Aufderheide ; MD^h ; Judy Powell ; BSN^c ; Brian Leroux ; PhD^c ; Christian Vaillancourt ; MDⁱ ; Jonathan Larsen^j ; Lynn Wittwer ; MD^k ; M. Riccardo Colella ; DO ; MPH^l ; Shannon W. Stephens ; EMT-P^m ; Mark Gamber ; DOⁿ ; Debra Egan ; MSc ; MPH^o ; Paul Dorian ; MD^p ; The Resuscitation Outcomes Consortium Investigators q
• 刊名：American Heart Journal
• 出版年：May 2014
• 年：2014
• 卷：167
• 期：5
• 页码：653-659.e4
• 全文大小：336 K

文摘

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.