NCT06680869 Early Amiodarone in Shockable Cardiac Arrest
| NCT ID | NCT06680869 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Oregon Health and Science University |
| Condition | Cardiac Arrest |
| Study Type | INTERVENTIONAL |
| Enrollment | 585 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 585 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Joshua Lupton, MD, MPH
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT06680869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06680869 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 585 participants.
Is NCT06680869 currently recruiting?
Yes, NCT06680869 is actively recruiting participants. Contact the research team at lupton@ohsu.edu for enrollment information.
Where is the NCT06680869 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06680869 clinical trial?
NCT06680869 is sponsored by Oregon Health and Science University. The principal investigator is Joshua Lupton, MD, MPH at Oregon Health and Science University. The trial plans to enroll 585 participants.