Epinephrine Dose: Optimal Versus Standard Evaluation Trial
NCT ID: NCT03826524
Last Updated: 2025-12-11
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
PHASE4
3790 participants
INTERVENTIONAL
2023-05-24
2028-12-31
Brief Summary
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Detailed Description
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Eligible OHCA patients will be treated by paramedics who will initiate cardiopulmonary resuscitation (CPR) and the delivery of defibrillation shocks per paramedic agencies' treatment protocols. After one defibrillation and when feasible, paramedics will establish peripheral intravenous (IV) access, and patients will be randomly allocated to either the low dose or standard dose treatment arm. Epinephrine doses (according to treatment assignment) will be administered every 3-5 minutes, based on current guidelines and paramedic protocols, until the first return of spontaneous circulation (ROSC) is achieved or if resuscitation has been terminated by the base hospital physician. Other medications (e.g. antiarrhythmics, magnesium, beta blockers) and interventions (e.g. intubation) may be interposed as required. Follow-up will take place using a combination of administrative databases (e.g. the Discharge Abstract Database and the National Ambulatory Care Reporting System) and telephone interviews.
This RCT will evaluate a fundamental change in the treatment of OHCA. The investigators hypothesize that a low cumulative dose of epinephrine will improve patient survival to hospital discharge compared to a standard cumulative dose of epinephrine. Please feel free to contact [email protected] for further information.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low Dose Epinephrine
Epinephrine up to 2mg total
Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Standard Dose Epinephrine
Epinephrine up to 6mg total
Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Interventions
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Epinephrine
Epinephrine 1mg 1:10000 (10cc) per dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or witnessed by EMS (paramedic or fire)
* Established intravenous vascular access
Exclusion Criteria
* Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics
* Cardiac arrest due to an obvious non-cardiac primary cause (e.g. blunt or penetrating trauma, exsanguination, burns, drug overdose, drowning, anaphylaxis, sudden asphyxiation, etc.)
* Administration of intramuscular, endotracheal tube, or intraosseous epinephrine
* Prisoners or persons in police custody
* Known allergy or sensitivity to epinephrine
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Dorian, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Steve Lin, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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British Columbia Emergency Health Services (BCEHS)
Victoria, British Columbia, Canada
Peel Regional Paramedic Services
Brampton, Ontario, Canada
Middlesex-London Paramedic Service
London, Ontario, Canada
Halton Region Paramedic Services
Oakville, Ontario, Canada
Ottawa Paramedic Services
Ottawa, Ontario, Canada
Superior North Emergency Medical Services
Thunder Bay, Ontario, Canada
Essex-Windsor Emergency Health Services
Windsor, Ontario, Canada
Medavie Health Services West
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EpiDOSE Protocol Version 3.0
Identifier Type: -
Identifier Source: org_study_id
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