Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Tachycardia; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation
Intervention: amiodarone; Lidocaine; Normal saline
Intervention description: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists.; 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists.; 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists.
Intervention MeSH terms: Lidocaine; Amiodarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3024.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrest; cardiopulmonary resuscitation; ventricular fibrillation; pulseless ventricular tachycardia; Non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Summary:

      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.
    

Eligibility criteria:

        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