Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
585 participants
INTERVENTIONAL
2025-01-01
2028-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Amiodarone Protocol
Amiodarone administration after the second defibrillator shock, during the same two-minute cycle as the initial dose of epinephrine.
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 amiodarone is dictated by the study.
Usual Care Protocol
Amiodarone administration after the third defibrillator shock, one two-minute cycle after the initial dose of epinephrine.
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 amiodarone is dictated by the study.
Interventions
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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 amiodarone is dictated by the study.
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 amiodarone is dictated by the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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Joshua Lupton
Principal Investigator
Principal Investigators
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Joshua Lupton, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Sciences University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Joshua Lupton, MD, MPH
Role: primary
Related Links
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Other Identifiers
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STUDY00026455
Identifier Type: -
Identifier Source: org_study_id