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NCT Number: NCT03826524

Epinephrine Dose: Optimal Versus Standard Evaluation Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

British Columbia Emergency Health Services (BCEHS), Victoria, British Columbia, Canada

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About this study

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 [email protected] for further information.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Out-of-hospital cardiac arrest treated by paramedics
  • 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

  • Known or apparent age <18 years
  • 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

Treatment and study plan

Epinephrine

Drug

Epinephrine 1mg 1:10000 (10cc) per dose

Other names: Adrenaline

Primary outcomes

  1. Survival to hospital discharge

    Time frame: Through study completion (up to 5 years)

    Individuals discharged alive from hospital

Secondary outcomes

  1. Return of spontaneous circulation in out-of-hospital setting

    Time frame: Through study completion (up to 5 years)

    Return of spontaneous circulation in the field

  2. Survival to emergency department arrival

    Time frame: Through study completion (up to 5 years)

    Individuals alive upon arrival to a hospital emergency department

  3. Survival to admission with death prior to discharge

    Time frame: Through study completion (up to 5 years)

    Individuals alive upon hospital admission who die in-hospital before being discharged

  4. Survival to discharge outside of a long-term healthcare facility e.g. nursing home

    Time frame: Through study completion (up to 5 years)

    Individuals discharged alive from hospital to a care facility

  5. Modified Rankin Scale (mRS) score

    Time frame: 12+/-3 months

    Assessment of neurological function, scores range from 0 to 6 where higher scores indicate worse neurological function (0=no symptoms, 6=dead)

  6. Health Utility Index-3 (HUI-3) score

    Time frame: 12+/-3 months

    Assessment of quality of life, scores range from -0.36 to 1 where higher scores indicate better quality life (negative scores=a state worse than being dead, 0=dead, 1=perfect health)

  7. Hospital Anxiety and Depression Scale score

    Time frame: 12+/-3 months

    Assessment of quality of life, scores range from 0 to 21 where higher scores indicate more anxiety/depression

  8. Length of stay in hospital

    Time frame: Through study completion (up to 5 years)

    Length of time an individual remained in-hospital (length in days)

  9. Length of stay in critical care unit

    Time frame: Through study completion (up to 5 years)

    Length of time an individual remained in a crucial care unit (length in days)

  10. Survival post-arrest

    Time frame: Up to 5 years

    Survival following hospital discharge, up to 5 years

  11. Recurrent cardiac arrest(s)

    Time frame: Up to 5 years

    Number of cardiac arrests following the index arrest

  12. ICD implant post-arrest

    Time frame: Up to 5 years

    Whether an implantable cardioverter defibrillator was implanted post-arrest

  13. Cardiovascular re-hospitalization(s)

    Time frame: Up to 5 years

    Number of cardiovascular re-hospitalizations

  14. All-cause re-hospitalizations(s)

    Time frame: Up to 5 years

    Number of re-hospitalizations for any reason

Study contacts

Contact information is provided by the study sponsor or research team.

Theresa Aves, MSc

CONTACT

[email protected]

416-864-6060 ext. 46787

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Pfizer

Registry information

Official study title

CanROC Epinephrine Dose: Optimal Versus Standard Evaluation Trial (CanROC EpiDOSE Trial)

Acronym: EpiDOSE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 1, 2019
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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