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 (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