Testing earlier amiodarone administration in cardiac arrest
Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study
PHASE3 · Oregon Health and Science University · NCT06680869
This study tests if giving amiodarone two minutes earlier during out-of-hospital cardiac arrest can help improve survival and brain function for patients with serious heart rhythms.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 585 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University (other) |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06680869 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate whether administering the initial dose of amiodarone two minutes earlier than current guidelines during out-of-hospital cardiac arrest improves patient outcomes. The study will compare this modified treatment algorithm against usual care for patients experiencing refractory ventricular fibrillation or ventricular tachycardia. Key outcomes include the time to amiodarone delivery, survival rates, and neurological status at hospital discharge. The trial employs a pragmatic stepped-wedge cluster randomized design to assess the effectiveness of the intervention in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing non-traumatic out-of-hospital cardiac arrest with an initial rhythm of ventricular fibrillation or ventricular tachycardia.
Not a fit: Patients with known allergies to amiodarone, pre-existing do-not-resuscitate orders, or those who are pediatric, pregnant, or prisoners may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and neurological outcomes for patients experiencing cardiac arrest.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- Oregon Health & Sciences University — Portland, Oregon, United States (RECRUITING)
Study contacts
- Principal investigator: Joshua Lupton, MD, MPH — Oregon Health and Science University
- Study coordinator: Joshua Lupton, MD, MPH
- Email: lupton@ohsu.edu
- Phone: (503) 418-6706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Arrest