Evaluating low versus standard doses of epinephrine for out-of-hospital cardiac arrest

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

This study tests whether giving a lower dose of epinephrine can help adults who have a cardiac arrest outside of the hospital more effectively than the standard higher dose.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3790 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Unity Health Toronto (Academic / other)
• Locations: 8 sites (Victoria, British Columbia and 7 other locations)
• Trial ID: NCT03826524 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to compare the effectiveness of a low cumulative dose of epinephrine (up to 2mg) against a standard cumulative dose (up to 6mg) in adult patients experiencing out-of-hospital cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia. Eligible patients will be treated by paramedics who will perform CPR and defibrillation, followed by the administration of epinephrine based on the assigned treatment group. The study will track outcomes until the return of spontaneous circulation is achieved or resuscitation is terminated, with follow-up conducted through administrative databases and interviews.

Who should consider this trial

Good fit: Ideal candidates are adults who have suffered an out-of-hospital cardiac arrest with a recorded initial rhythm of ventricular fibrillation or pulseless ventricular tachycardia.

Not a fit: Patients who are under 18 years old or have a cardiac arrest due to a non-cardiac cause will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and neurological outcomes for patients experiencing out-of-hospital cardiac arrest.

How similar studies have performed: Other studies have explored epinephrine dosing in cardiac arrest, but this specific low-dose approach is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Victoria, British Columbia and 7 other locations

• British Columbia Emergency Health Services (BCEHS) — Victoria, British Columbia, Canada (Recruiting)
• Peel Regional Paramedic Services — Brampton, Ontario, Canada (Recruiting)
• Middlesex-London Paramedic Service — London, Ontario, Canada (Recruiting)
• Halton Region Paramedic Services — Oakville, Ontario, Canada (Recruiting)
• Ottawa Paramedic Services — Ottawa, Ontario, Canada (Recruiting)
• Superior North Emergency Medical Services — Thunder Bay, Ontario, Canada (Recruiting)
• Essex-Windsor Emergency Health Services — Windsor, Ontario, Canada (Recruiting)
• Medavie Health Services West — Saskatoon, Saskatchewan, Canada (Recruiting)

Study contacts

• Principal investigator: Paul Dorian, MD, MSc — Unity Health Toronto
• Study coordinator: Theresa Aves, MSc

Conditions Cardiac Arrest, Out-Of-Hospital; Sudden Cardiac Arrest; Ventricular Fibrillation; Ventricular Tachycardia-Pulseless; out-of-hospital cardiac arrest; sudden cardiac arrest; epinephrine; randomized controlled trial