Clinical trial NCT06680869: Early Amiodarone in Shockable Cardiac Arrest
Official title: Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiac Arrest
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-11-08
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

The null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.

Evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.

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

Primary outcomes:
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
timeFrame: up to 1 day
Secondary outcomes:
measure: The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator
timeFrame: up to 1 day
measure: The number and proportion of patients with pulses present and documented by emergency medical services at the time of patient care transfer to hospital staff at emergency department arrival
timeFrame: up to 1 day
measure: The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department
timeFrame: up to 1 day
measure: 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
timeFrame: up to 30 days
measure: 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
timeFrame: up to 30 days
measure: 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
timeFrame: up to 1 day
measure: Number and proportion of participants with adverse events
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Joshua Lupton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: