3790 Participants Needed

Epinephrine Dosing for Cardiac Arrest

(EpiDOSE Trial)

Recruiting at 2 trial locations
TA
Overseen ByTheresa Aves, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Unity Health Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug epinephrine for cardiac arrest?

Research suggests that higher doses of epinephrine may improve blood flow to the heart and brain during cardiac arrest, potentially leading to better survival rates. However, the traditional dose has little scientific basis, and more studies are needed to confirm the benefits of higher doses in humans.12345

Is epinephrine generally safe for use in humans?

Epinephrine is generally safe for use in humans, but incorrect dosing can lead to serious complications. For example, giving a high dose meant for cardiac arrest to someone with an allergic reaction can cause severe heart problems. Proper labeling and packaging can help prevent these errors.15678

How is the drug epinephrine unique in treating cardiac arrest?

Epinephrine is unique in treating cardiac arrest because it is administered intravenously every 3-5 minutes to improve blood flow to the heart and brain, and there is ongoing research to determine the optimal dosing period and amount, which may vary based on the duration of the cardiac arrest.124910

What is the purpose of this trial?

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.

Research Team

SL

Steve Lin, MD, MSc

Principal Investigator

St. Michael's Hospital

PD

Paul Dorian, MD, MSc

Principal Investigator

St. Michael's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I was treated by paramedics for a cardiac arrest that happened outside of a hospital.
Established intravenous vascular access
My first heart rhythm issue was treated or seen by emergency services.

Exclusion Criteria

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.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediate

Treatment

Eligible OHCA patients receive either a low or standard cumulative dose of epinephrine during resuscitation

Immediate
On-site during emergency response

Follow-up

Participants are monitored for survival to hospital discharge and other outcomes using administrative databases and telephone interviews

Up to 5 years

Treatment Details

Interventions

  • Epinephrine
Trial Overview 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.
Participant Groups
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

Epinephrine is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Epinephrine for:
  • Anaphylaxis
  • Cardiac arrest
  • Severe allergic reactions
🇺🇸
Approved in United States as Epinephrine for:
  • Anaphylaxis
  • Cardiac arrest
  • Severe allergic reactions
🇨🇦
Approved in Canada as Epinephrine for:
  • Anaphylaxis
  • Cardiac arrest
  • Severe allergic reactions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

In a study of 20,909 in-hospital cardiac arrest events, administering epinephrine less frequently than the recommended 3-5 minute intervals was associated with higher survival rates to hospital discharge.
Specifically, longer average dosing periods (6-10 minutes) resulted in significantly improved survival odds, suggesting that the traditional dosing guidelines may need reevaluation for better patient outcomes.
Adrenaline (epinephrine) dosing period and survival after in-hospital cardiac arrest: a retrospective review of prospectively collected data.Warren, SA., Huszti, E., Bradley, SM., et al.[2021]
In a study involving 28 male pigs, high-dose adrenaline (HDA) improved the chances of successful resuscitation after 13 minutes of cardiac arrest compared to standard-dose adrenaline (SDA), with all animals in the HDA group being resuscitated.
Despite the initial success in restoring circulation with HDA, there was no significant improvement in long-term survival or neurological outcomes, indicating that higher doses may not enhance overall recovery after cardiac arrest.
Variable effects of high-dose adrenaline relative to standard-dose adrenaline on resuscitation outcomes according to cardiac arrest duration.Jeung, KW., Ryu, HH., Song, KH., et al.[2013]
In a study of 15,909 patients with out-of-hospital cardiac arrest, shorter average dosing intervals of epinephrine (less than 3 minutes) were linked to better survival rates with favorable neurological outcomes at hospital discharge.
Longer dosing intervals (3 to 5 minutes or more) significantly decreased the odds of survival with favorable neurologic status, suggesting that administering epinephrine more frequently may improve patient outcomes.
The Association of the Average Epinephrine Dosing Interval and Survival With Favorable Neurologic Status at Hospital Discharge in Out-of-Hospital Cardiac Arrest.Grunau, B., Kawano, T., Scheuermeyer, FX., et al.[2020]

References

Adrenaline (epinephrine) dosing period and survival after in-hospital cardiac arrest: a retrospective review of prospectively collected data. [2021]
Variable effects of high-dose adrenaline relative to standard-dose adrenaline on resuscitation outcomes according to cardiac arrest duration. [2013]
The Association of the Average Epinephrine Dosing Interval and Survival With Favorable Neurologic Status at Hospital Discharge in Out-of-Hospital Cardiac Arrest. [2020]
High-dose epinephrine in adult cardiac arrest. [2022]
Epinephrine in cardiopulmonary resuscitation. [2019]
A comparison of standard-dose and high-dose epinephrine in cardiac arrest outside the hospital. The Multicenter High-Dose Epinephrine Study Group. [2013]
Confusion about epinephrine dosing leading to iatrogenic overdose: a life-threatening problem with a potential solution. [2022]
[Which dosage concept for adrenaline is correct in cardiopulmonary resuscitation? A data analysis of preclinical resuscitations]. [2013]
Lower-dose epinephrine administration and out-of-hospital cardiac arrest outcomes. [2018]
Adrenaline dosage during cardiopulmonary resuscitation: a critical review. [2013]
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