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Catecholamine

Epinephrine Dosing for Cardiac Arrest (EpiDOSE Trial)

Phase 4
Recruiting
Led By Paul Dorian, MD, MSc
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
Known or apparent age <18 years
Prior receipt of non-study kit intravenous, intraosseous, or intramuscular epinephrine during resuscitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if lower epinephrine doses work better to save people in cardiac arrest outside of hospitals.

Who is the study for?
This trial is for adults who've had a cardiac arrest outside of the hospital with specific heart rhythms (VF or pulseless VT) and were treated by paramedics. They must have IV access established. It's not for those under 18, non-cardiac caused arrests, prisoners, people allergic to epinephrine, or if they've already received epinephrine.
What is being tested?
The study tests whether a lower total dose of epinephrine is as effective as the standard dose during resuscitation from certain types of cardiac arrest. Participants are randomly assigned to receive either the low or standard dose.
What are the potential side effects?
Epinephrine can cause rapid heartbeat, high blood pressure, anxiety, dizziness, headache and may lead to more serious effects like irregular heartbeats or heart attack in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was treated by paramedics for a cardiac arrest that happened outside of a hospital.
Select...
My first heart rhythm issue was treated or seen by emergency services.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
Select...
I have received epinephrine not from this study for resuscitation.
Select...
I experienced a cardiac arrest due to a clear non-heart related cause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Survival to hospital discharge
Secondary study objectives
All-cause re-hospitalizations(s)
Cardiovascular re-hospitalization(s)
Health Utility Index-3 (HUI-3) score
+11 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Low Dose EpinephrineActive Control1 Intervention
Epinephrine up to 2mg total
Group II: Standard Dose EpinephrineActive Control1 Intervention
Epinephrine up to 6mg total

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
450,616 Total Patients Enrolled
3 Trials studying Cardiac Arrest
1,561 Patients Enrolled for Cardiac Arrest
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,514,283 Total Patients Enrolled
7 Trials studying Cardiac Arrest
7,165 Patients Enrolled for Cardiac Arrest
PfizerIndustry Sponsor
4,660 Previous Clinical Trials
17,873,565 Total Patients Enrolled

Media Library

Epinephrine (Catecholamine) Clinical Trial Eligibility Overview. Trial Name: NCT03826524 — Phase 4
Cardiac Arrest Research Study Groups: Low Dose Epinephrine, Standard Dose Epinephrine
Cardiac Arrest Clinical Trial 2023: Epinephrine Highlights & Side Effects. Trial Name: NCT03826524 — Phase 4
Epinephrine (Catecholamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826524 — Phase 4
~2527 spots leftby Dec 2027
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