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Early Amiodarone in Shockable Cardiac Arrest

Early Amiodarone in Shockable Cardiac Arrest

Recruiting
18 years and older
All
Phase 3

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Overview

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

Description

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

The null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.

Evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.

Eligibility

Inclusion Criteria:

  • Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest
  • Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia
  • Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt

Exclusion Criteria:

  • Known allergy to amiodarone
  • EMS-assessed contraindication to amiodarone
  • Pre-existing "do-not-attempt-resuscitation" orders
  • Inter-facility transportations
  • Initial care by a non-participating EMS agency able to perform advanced life support interventions
  • Pediatric patient as determined by EMS
  • Prisoners
  • Pregnant patients

Study details
    Cardiac Arrest

NCT06680869

Oregon Health and Science University

16 October 2025

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