Back to Trials
NCT06680869PHASE3Recruiting

Early Amiodarone in Shockable Cardiac Arrest

Oregon Health and Science University

Start Date

1/1/2025

Completion Date

1/31/2028

Summary

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Amiodarone Hydrochloride Injection

OTHER

Usual Care Protocol

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Cardiac Arrest

Locations

Oregon Health & Sciences University

Portland, Oregon 97035

United States