Recruiting

Phase 4

Epinephrine DoseEpinephrine Dose: Optimal Versus Standard Evaluation Trial

Sponsor:

Unity Health Toronto

Code:

NCT03826524

Conditions

Cardiac Arrest, Out-Of-Hospital

Sudden Cardiac Arrest

Ventricular Fibrillation

Ventricular Tachycardia-Pulseless

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epinephrine

Study Details

Brief summary:

The objective of this randomized controlled trial is to evaluate whether a low cumulative dose of epinephrine ("low dose") is non-inferior to a standard cumulative dose of epinephrine ("standard dose") with respect to survival to hospital discharge among adults undergoing resuscitation for OHCA due to ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT).

Conditions

Cardiac Arrest, Out-Of-Hospital

Sudden Cardiac Arrest

Ventricular Fibrillation

Ventricular Tachycardia-Pulseless

Study ID

NCT03826524

Start date

May 24, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Out-of-hospital cardiac arrest treated by paramedics AND
Initial recorded cardiac rhythm of VF or pulseless VT, or, AED shock on first analysis administered or confirmed by paramedics or fire services, AND
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

Study Design

Enrollment

1250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low Dose Epinephrine

Epinephrine up to 2mg total

active comparator: Standard Dose Epinephrine

Epinephrine up to 6mg total

Interventions

Epinephrine

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

Primary outcome measure

Survival to hospital discharge [ Time Frame: Through study completion (up to 5 years) ]

Central Contacts and Locations

Central contacts

Theresa Aves, MSc

416-864-6060 theresa.aves@unityhealth.to

Locations

British Columbia Emergency Health Services (BCEHS)

Recruiting

Victoria, British Columbia, Canada, V8W 9P1

Contacts

Helen Connolly

604-806-8753 HConnolly@providencehealth.bc.ca

Principal Investigator:

Brian Grunau, MD

Peel Regional Paramedic Services

Recruiting

Brampton, Ontario, Canada, L6T 4B9

Contacts

Theresa Aves

416-864-6060 theresa.aves@unityhealth.to

Principal Investigator:

Sheldon Cheskes, MD

Middlesex-London Paramedic Service

Recruiting

London, Ontario, Canada, N6E 1R4

Contacts

Manya Charette

613-798-5555 mancharette@ohri.ca

Principal Investigator:

Christian Vaillancourt, MD

Halton Region Paramedic Services

Recruiting

Oakville, Ontario, Canada, L6M 3L1

Contacts

Theresa Aves

416-864-6060 epidose@unityhealth.to

Principal Investigator:

Sheldon Cheskes, MD

Ottawa Paramedic Services

Recruiting

Ottawa, Ontario, Canada, K1H 1E2

Contacts

Manya Charette

613-798-5555 mancharette@ohri.ca

Principal Investigator:

Christian Vaillancourt, MD

Superior North Emergency Medical Services

Recruiting

Thunder Bay, Ontario, Canada, P7B 4X6

Contacts

Manya Charette

613-798-5555 mancharette@ohri.ca

Principal Investigator:

Christian Vaillancourt, MD

Region of Waterloo Paramedic Services

Recruiting

Waterloo, Ontario, Canada, N2G 4J3

Contacts

Kathy Winter, MD

905-521-2100 winterkat@hhsc.ca

Principal Investigator:

Paul Miller, MD

Essex-Windsor Emergency Health Services

Recruiting

Windsor, Ontario, Canada, N9A 1N6

Contacts

Manya Charette

613-798-5555 mancharette@ohri.ca

Principal Investigator:

Christian Vaillancourt, MD

Medavie Health Services West

Recruiting

Saskatoon, Saskatchewan, Canada, S7J 4M2

Contacts

Tracy Wilson, PhD

306-655-2810 tracy.wilson@usask.ca

Principal Investigator:

Andrew Leach, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Oct 2, 2026

Last verified

Dec, 2025

Keywords

out-of-hospital cardiac arrest
sudden cardiac arrest
epinephrine
randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.