NCT03826524

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,790

participants targeted

Target at P75+ for phase_4

Timeline
31mo left

Started May 2023

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
May 2023Dec 2028

First Submitted

Initial submission to the registry

November 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
4.3 years until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4.5 years

First QC Date

November 7, 2018

Last Update Submit

December 9, 2025

Conditions

Cardiac Arrest, Out-Of-HospitalSudden Cardiac ArrestVentricular FibrillationVentricular Tachycardia-Pulseless

Keywords

out-of-hospital cardiac arrestsudden cardiac arrestepinephrinerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Survival to hospital discharge

    Individuals discharged alive from hospital

    Through study completion (up to 5 years)

Secondary Outcomes (14)

  • Return of spontaneous circulation in out-of-hospital setting

    Through study completion (up to 5 years)

  • Survival to emergency department arrival

    Through study completion (up to 5 years)

  • Survival to admission with death prior to discharge

    Through study completion (up to 5 years)

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

    Through study completion (up to 5 years)

  • Modified Rankin Scale (mRS) score

    12+/-3 months

  • +9 more secondary outcomes

Study Arms (2)

Low Dose Epinephrine

ACTIVE COMPARATOR

Epinephrine up to 2mg total

Drug: Epinephrine

Standard Dose Epinephrine

ACTIVE COMPARATOR

Epinephrine up to 6mg total

Drug: Epinephrine

Interventions

EpinephrineDRUG

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

Also known as: Adrenaline
Low Dose EpinephrineStandard Dose Epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

British Columbia Emergency Health Services (BCEHS)

Victoria, British Columbia, V8W 9P1, Canada

RECRUITING

Peel Regional Paramedic Services

Brampton, Ontario, L6T 4B9, Canada

RECRUITING

Middlesex-London Paramedic Service

London, Ontario, N6E 1R4, Canada

RECRUITING

Halton Region Paramedic Services

Oakville, Ontario, L6M 3L1, Canada

RECRUITING

Ottawa Paramedic Services

Ottawa, Ontario, K1H 1E2, Canada

RECRUITING

Superior North Emergency Medical Services

Thunder Bay, Ontario, P7B 4X6, Canada

RECRUITING

Essex-Windsor Emergency Health Services

Windsor, Ontario, N9A 1N6, Canada

RECRUITING

Medavie Health Services West

Saskatoon, Saskatchewan, S7J 4M2, Canada

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestDeath, Sudden, CardiacVentricular Fibrillation

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, Cardiac

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Paul Dorian, MD, MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Steve Lin, MD, MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Aves, MSc

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

February 1, 2019

Study Start

May 24, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(8)