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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
EpiDOSE 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.Check my eligibility
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.See study design
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.
EpiDOSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
EpiDOSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival to hospital discharge
Secondary outcome measures
All-cause re-hospitalizations(s)
Cardiovascular re-hospitalization(s)
Health Utility Index-3 (HUI-3) score
+11 moreEpiDOSE 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
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Who is running the clinical trial?
Unity Health TorontoLead Sponsor
540 Previous Clinical Trials
443,990 Total Patients Enrolled
3 Trials studying Cardiac Arrest
1,561 Patients Enrolled for Cardiac Arrest
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,449,777 Total Patients Enrolled
7 Trials studying Cardiac Arrest
13,262 Patients Enrolled for Cardiac Arrest
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,912,213 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was treated by paramedics for a cardiac arrest that happened outside of a hospital.I am under 18 years old.Your heart stopped beating at the beginning of the emergency.People who are in jail or being held by the police.My first heart rhythm issue was treated or seen by emergency services.You have a known allergy or sensitivity to epinephrine.I have received epinephrine not from this study for resuscitation.I experienced a cardiac arrest due to a clear non-heart related cause.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Epinephrine
- Group 2: Standard Dose Epinephrine
Awards:
This trial has 5 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available in this clinical trial?
"As verified on clinicaltrials.gov, this medical experiment is presently recruiting participants. It was first made available on May 24th 2023 and had its last revision on June 6th of the same year."
Answered by AI
Has the Federal Drug Administration given its stamp of approval to Standard Dose Epinephrine?
"Due to it being a Phase 4 trial, which indicates that this medication has already been approved for use, Standard Dose Epinephrine scored 3 on our team's safety scale."
Answered by AI
What medical circumstances is Standard Dose Epinephrine regularly administered for?
"Standard Dose Epinephrine is commonly used to address low blood pressure. Additionally, it can be employed to combat unresponsive bradycardia, pupil abnormalities, and open angle glaucoma."
Answered by AI
Has there been precedent for utilizing Standard Dose Epinephrine in past clinical trials?
"Presently, 29 medical trials researching Standard Dose Epinephrine are still in progress with 3 of them being at Phase 3. Most experiments for this drug take place in San Diego, California; however, 43 other clinical centres around the country also host studies on Standard Dose Epinephrine."
Answered by AI
How many people have been recruited for this research endeavor?
"Affirmative. Clinicaltrials.gov states that this clinical trial is recruiting patients; the study was first posted on May 24th, 2023 and last updated on June 6th, 2023. It aims to enrol 3790 individuals across one site of research."
Answered by AI
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