Cardiac Arrest Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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