NCT03826524 Epinephrine Dose: Optimal Versus Standard Evaluation Trial
| NCT ID | NCT03826524 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Unity Health Toronto |
| Condition | Cardiac Arrest, Out-Of-Hospital |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,790 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,790 participants in total. It began in 2023-05-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Paul Dorian, MD, MSc
PRINCIPAL INVESTIGATOR
Unity Health Toronto
Frequently Asked Questions
Who can join the NCT03826524 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest, Out-Of-Hospital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03826524 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03826524 currently recruiting?
Yes, NCT03826524 is actively recruiting participants. Contact the research team at theresa.aves@unityhealth.to for enrollment information.
Where is the NCT03826524 trial being conducted?
This trial is being conducted at Victoria, Canada, Brampton, Canada, London, Canada, Oakville, Canada and 4 additional locations.
Who is sponsoring the NCT03826524 clinical trial?
NCT03826524 is sponsored by Unity Health Toronto. The principal investigator is Paul Dorian, MD, MSc at Unity Health Toronto. The trial plans to enroll 3,790 participants.