Peel Regional Paramedic Services (PRPS), a recognized leader in prehospital research, will started two new randomized controlled trials in July 2012: the ROC ALPS study (Amidoarone, Lidocaine or Neither for Out-of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Ventricular Tachycardia) and the ICEPACS trial (Initiation of Cooling by Emergency Medical Services to Promote the Adoption of In-Hospital Therapeutic Hypothermia in Cardiac Arrest Survivors).
Both trials are approved by the Research Ethics Boards and will run in conjunction with the current ROC CCC (Continuous Compression vs. 30:2 CPR) trial, which began one year ago. Peel is one of 11 sites across North America participating in the ROC ALPS trial, and will join several of its southern Ontario neighbours, including Halton, Toronto and York, in the ICEPACS trial.
ROC ALPS will attempt to answer, in a large randomized controlled trial, whether antiarrhythmic agents, such as Amiodarone and Lidocaine, improve survival from out-of-hospital cardiac arrest due to ventricular fibrillation. Previous studies in Toronto (ALIVE) and Seattle (ARREST) showed improvement to return of spontaneous circulation through the use of Amiodarone, but no improvement to survival was noted in either study. Both studies were carried out over 10 years ago and used Advanced Cardiac Life Support (ACLS) guidelines, which differ (stacked shocks vs. single shocks) from current guidelines. The study will also focus on early administration of ALPS drug – when compared to current ACLS guidelines – with a new FDA formulation of Amiodarone (Nexterone). The addition of a placebo arm in the trial comes in the wake of recent work in Norway that suggested cardiac arrest treated with CPR and no drugs seemed to produce survival rates similar to cardiac arrest treated with full ACLS protocol.
Dr. Sheldon Cheskes, Medical Director, Sunnybrook Centre for Prehospital Medicine and Co-Principal Investigator for the Toronto site of the Resuscitation Outcomes Consortium says, “This in my mind, will be the landmark trial for antiarrhythmic use in shockable cardiac arrest. The large enrollment will allow this trial to be powered sufficiently to definitively answer this question. The large variety of EMS services across North America taking part in the trial will speak well of the applicability of the results to other systems once completed. “
In the ICEPACS trial, Peel Regional Paramedic Services will be the first service in Ontario to provide prehospital hypothermia to non-responsive survivors of out-of-hospital cardiac arrest. Through work performed by the SPARC (Strategies for Post Arrest Care) network it has become apparent that in-hospital cooling for this subgroup of patients remains unacceptably low in Ontario, despite strong scientific evidence of its benefit.
“The goal of this trial is not to prove the benefit of hypothermia, as this has already been proven, but rather to determine whether the application of cooling by EMS increases the rate of in-hospital cooling,” says Dr. Cheskes. “By taking part in this trial, Peel Regional Paramedic Services will be able to ensure that optimal, state of the art, post resuscitation care is provided to all survivors of cardiac arrest. Peel Regional Paramedic Services has always enjoyed one of the highest rates of survival from shockable cardiac arrest in North America. Participation in this trial can only further improve these excellent results.”
Dr. Cheskes believes the commitment to research shown by PRPS in these two trials is unprecedented. “From extra training time to purchasing extra coolers and fridges for the ICEPACS trial, Peel Regional Paramedic Services continues to show an appetite for not only high quality prehospital research, but setting a standard of excellence in cardiac arrest care for their patients.”
PRPS was recently recognized by the Resuscitation Outcomes Consortium for being the first site in North America to enroll patients in both the ROC PRIMED and ROC CCC research trials.
Peel Paramedics respond to more than 85,000 emergency medical calls every year. PRPS employs approximately 500 full-time and part-time Primary and Advanced Care Paramedics and 80 management and support staff. The service is responsible to care for more than 1.3 million people in Peel Region.