Amiodarone for Cardiac Arrest (Early-Amio Trial)

Phase 3

Waitlist Available

Led By Joshua Lupton, MD, MPH

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest

Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt

Must not have

Initial care by a non-participating EMS agency able to perform advanced life support interventions

EMS-assessed contraindication to amiodarone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see if giving amiodarone earlier during a cardiac arrest, at the same time as epinephrine, can improve the time it takes for patients to receive the medication.

Who is the study for?

This trial is for individuals who have had a non-traumatic out-of-hospital cardiac arrest with an initial heart rhythm of ventricular fibrillation or tachycardia, and the condition persists after one defibrillation attempt. It's not for those with amiodarone contraindications, pre-existing 'do-not-resuscitate' orders, prisoners, pregnant women, children as determined by EMS, or known allergy to amiodarone.

What is being tested?

The study tests if giving Amiodarone Hydrochloride Injection earlier than current guidelines improves time to delivery in patients with refractory ventricular fibrillation/tachycardia during cardiac arrest. This is compared to usual care where it's given later according to existing protocols.

What are the potential side effects?

Amiodarone can cause side effects like low blood pressure or slowed heart rate when administered during resuscitation. Other potential reactions include issues related to thyroid function, lung inflammation, liver enzyme changes and skin discoloration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was treated by EMS for a sudden heart stoppage not caused by injury.

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My heart condition did not improve after one defibrillation attempt.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My first emergency care was provided by a qualified team not in this study.

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I cannot take amiodarone due to a specific medical reason.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number and proportion of participants with adverse events

The number and proportion of patients surviving to be discharged from the hospital (or 30 days, whichever is sooner) after their admission for cardiac arrest with a Cerebral Performance Category score of 1 or 2

Time from emergency medical services (EMS) arrival on-scene (or time of arrest if witnessed by EMS) to the delivery of other critical interventions in minutes