Early Amiodarone in Shockable Cardiac Arrest

Last updated: March 17, 2025
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

3

Condition

Heart Failure

Circulation Disorders

Heart Attack (Myocardial Infarction)

Treatment

Usual Care Protocol

Amiodarone Hydrochloride Injection

Clinical Study ID

NCT06680869
STUDY00026455
1K23HL173647-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiacarrest

  • Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventriculartachycardia

  • Recurrence or persistence of ventricular fibrillation or ventricular tachycardiaafter one defibrillation attempt

Exclusion

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 supportinterventions

  • Pediatric patient as determined by EMS

  • Prisoners

  • Pregnant patients

Study Design

Total Participants: 585
Treatment Group(s): 2
Primary Treatment: Usual Care Protocol
Phase: 3
Study Start date:
January 01, 2025
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • Oregon Health & Sciences University

    Portland, Oregon 97035
    United States

    Active - Recruiting

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