Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Washington
With
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
U.S. Army Medical Research and Development Command
The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (PM101) compared to placebo.
The corresponding null hypothesis is that survival to hospital discharge is identically distributed when out-of-hospital VF/VT arrest is treated with PM101 or placebo.
The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of:
1. Lidocaine compared to placebo
2. PM101 compared to lidocaine The corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital VF/VT arrest is treated with lidocaine as compared with placebo, and with PM101 as compared with lidocaine.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age at least 18 years or local age of consent
Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability
VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity)
Incessant or recurrent VF/VT after receipt of ≥ 1 shocks
Established vascular access
You may not be if
Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT
Written advance directive to not attempt resuscitation (DNAR)
Blunt, penetrating, or burn-related injury
Exsanguination
Protected populations (prisoners, pregnancy, children under local age of consent)
Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers
Prior receipt of open label lidocaine or amiodarone during resuscitation
Clareo Health | Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
