RecruitingPhase 3NCT06680869

Early Amiodarone in Shockable Cardiac Arrest

Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study


Sponsor

Oregon Health and Science University

Enrollment

585 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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Interventions

DRUGAmiodarone Hydrochloride Injection

The use of a modified treatment protocol by emergency medical services where the initial dose of amiodarone is given after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.

OTHERUsual Care Protocol

The use of a usual care treatment protocol by emergency medical services where the initial dose of amiodarone is given after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodarone is dictated by the study.


Locations(1)

Oregon Health & Sciences University

Portland, Oregon, United States

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NCT06680869


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