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 (VF) or Ventricular Tachycardia (VT)

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