Early Amiodarone in Shockable Cardiac Arrest

Conditions

• Cardiac Arrest

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amiodarone Hydrochloride Injection — DRUG
  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.
• Usual Care Protocol — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jan 1, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

585 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Early Amiodarone Protocol
  Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.
• Active Comparator: Usual Care Protocol
  Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.

Primary Outcome Measure

Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the administration of the initial dose of amiodarone in minutes [ Time Frame: up to 1 day ]

Central Contacts

• Joshua Lupton, MD, MPH
  (503) 418-6706
  [email protected]

Locations (1)

Find similar trials in Portland, OR

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