Recruiting PHASE3 Cardiac Arrest

New treatment option for Cardiac Arrest

Official title Early Amiodarone in Shockable Cardiac Arrest

ClinicalTrials.gov ID: NCT06680869

What this study is testing

What is Amiodarone Hydrochloride Injection?

Amiodarone Hydrochloride Injection is an investigational medicine, being studied as a potential treatment for cardiac arrest.

Also referred to as Early-Amiodarone Protocol.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Portland, Oregon, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.