Epinephrine Dose: Optimal Versus Standard Evaluation Trial

Last updated: July 10, 2024
Sponsor: Unity Health Toronto
Overall Status: Active - Recruiting

Phase

4

Condition

Arrhythmia

Fast Heart Rate (Tachycardia)

Dysrhythmia

Treatment

Epinephrine

Clinical Study ID

NCT03826524
EpiDOSE Protocol Version 2.2
  • Ages > 18
  • All Genders

Study Summary

The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Out-of-hospital cardiac arrest treated by paramedics

  • Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on firstanalysis administered or witnessed by EMS (paramedic or fire)

  • Established intravenous vascular access

Exclusion

Exclusion Criteria:

  • Known or apparent age <18 years

  • Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on firstanalysis administered or confirmed by paramedics

  • Cardiac arrest due to an obvious non-cardiac primary cause (e.g. blunt orpenetrating 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

Study Design

Total Participants: 3790
Treatment Group(s): 1
Primary Treatment: Epinephrine
Phase: 4
Study Start date:
May 24, 2023
Estimated Completion Date:
June 30, 2028

Study Description

This study is designed as a prospective, multicentre, single-blinded randomized controlled trial (RCT) where eligible OHCA patients are randomized to receive a low cumulative dose of epinephrine (low dose epinephrine, up to 2mg total) or a standard cumulative dose of epinephrine (standard dose epinephrine, up to 6mg total) in a 1:1 fashion.

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 epidose@unityhealth.to for further information.

Connect with a study center

  • British Columbia Emergency Health Services (BCEHS)

    Victoria, British Columbia V8W 9P1
    Canada

    Active - Recruiting

  • Halton Region Paramedic Services

    Halton, Ontario L6M 3L1
    Canada

    Active - Recruiting

  • Ottawa Paramedic Services

    Ottawa, Ontario K1H 1E2
    Canada

    Active - Recruiting

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