Early Amiodarone in Shockable Cardiac Arrest

Official title

Early Amiodarone in Shockable Cardiac Arrest (Early-Amio) Study

Overview

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.

Interventions

• Drug Amiodarone Hydrochloride Injection
  The use of a modified treatment protocol by emergency medical services where the initial dose of amiodarone is given after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of a
• Other Usual Care Protocol
  The use of a usual care treatment protocol by emergency medical services where the initial dose of amiodarone is given after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine, for out-of-hospital cardiac arrest due to a shockable rhythm (ventricular fibrillation or ventricular tachycardia) that is persistent or recurs after at least one defibrillation attempt. If an EMS agency is assigned to this arm, no downstream care after the initial dose of amiodaron

Primary outcome measures

• 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 [Time frame: up to 1 day]

Secondary outcome measures (7)

• The number and proportion of patients receiving the initial dose of amiodarone from emergency medical services before the third shock from a defibrillator [Time frame: up to 1 day]
• 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 [Time frame: up to 1 day]
• The number and proportion of patients surviving to be admitted to inpatient services after arrival to the emergency department [Time frame: up to 1 day]
• 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 [Time frame: up to 30 days]
• 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 frame: up to 30 days]
• 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 [Time frame: up to 1 day]
• Number and proportion of participants with adverse events [Time frame: up to 1 day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Oregon Health & Sciences University — Portland

Identifiers

NCT: NCT06680869 · STUDY00026455 · 1K23HL173647-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗