Early Amiodarone in Shockable Cardiac Arrest (Early-Amio)

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 3

Conditions: Cardiac Arrest

Treatments: Other: Usual Care Protocol; Drug: Amiodarone Hydrochloride Injection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06680869

STUDY00026455

1K23HL173647-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 585 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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585 participants in 2 patient groups

Early Amiodarone Protocol

Experimental group

Description:

Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.

Treatment:

Drug: Amiodarone Hydrochloride Injection

Usual Care Protocol

Active Comparator group

Description:

Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.

Treatment:

Other: Usual Care Protocol