Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
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 (Nexterone-PM101) compared to placebo.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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