Recruiting
Phase 3

Amiodarone

Sponsor:

Oregon Health and Science University

Code:

NCT06680869

Conditions

Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amiodarone Hydrochloride Injection

Usual Care Protocol

Study Details

Brief 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.

Conditions

Cardiac Arrest

Study ID

NCT06680869

Start date

Jan 1, 2025

Status verified date

Dec, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

585 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Amiodarone 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.

Usual 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.

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 and Locations

Central contacts

Joshua Lupton, MD, MPH

(503) 418-6706lupton@ohsu.edu

Locations

Oregon Health & Sciences University

Recruiting

Portland, Oregon, United States, 97035

Contacts

Joshua Lupton, MD, MPH

503-418-6706lupton@ohsu.edu

Principal Investigator:

Joshua Lupton, MD, MPH

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-12-19.