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Adrenergic Agonist

Intramuscular Epinephrine for Out-of-Hospital Cardiac Arrest (PRIME Trial)

Phase 2 & 3
Recruiting
Led By Janice Tijssen, MD MSc
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)
Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dependent on course of hospital stay, up to 1 year
Awards & highlights

PRIME Trial Summary

This trial will test whether early intramuscular epinephrine can improve outcomes in pediatric out-of-hospital cardiac arrest.

Who is the study for?
This trial is for children from birth up to 17 years old who have had a cardiac arrest outside of the hospital and are receiving CPR by trained responders. It's not for those whose cardiac arrest was caused by a clear injury.Check my eligibility
What is being tested?
The study tests if giving epinephrine as an injection into the muscle early on helps in treating kids with out-of-hospital cardiac arrests. It randomly assigns participants to two groups over time to compare outcomes.See study design
What are the potential side effects?
While specific side effects aren't listed, generally, IM epinephrine can cause rapid heart rate, high blood pressure, tremors, headache, nausea and anxiety.

PRIME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I received CPR from a trained responder for at least 1 minute.
Select...
My child, aged 17 or younger, had a cardiac arrest outside of a hospital.

PRIME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dependent on course of hospital stay, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and dependent on course of hospital stay, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to initial return of spontaneous circulation (ROSC)
Secondary outcome measures
Life Impact and Pediatric Quality of Life assessments
Neurological status
PCCU/Hospital length of stay
+6 more

PRIME Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intramuscular Epinephrine DoseExperimental Treatment1 Intervention
POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector and/or pre-filled syringes. Dosing will be dependent on weight as follows: 3-<5kg=0.3mg IM epinephrine 5-<10kg=0.5mg IM epinephrine 10-<20kg=1.0mg IM epinephrine 20-<30kg=2.0mg IM epinephrine 30kg=3.0mg IM epinephrine
Group II: Standard of CareActive Control1 Intervention
All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
655 Previous Clinical Trials
413,055 Total Patients Enrolled
1 Trials studying Out-of-Hospital Cardiac Arrest
75 Patients Enrolled for Out-of-Hospital Cardiac Arrest
Janice Tijssen, MD MScPrincipal InvestigatorLawson Health Research Institute

Media Library

Epinephrine Injection (Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05166343 — Phase 2 & 3
Out-of-Hospital Cardiac Arrest Research Study Groups: Standard of Care, Intramuscular Epinephrine Dose
Out-of-Hospital Cardiac Arrest Clinical Trial 2023: Epinephrine Injection Highlights & Side Effects. Trial Name: NCT05166343 — Phase 2 & 3
Epinephrine Injection (Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166343 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary conditions that this therapy is designed to mitigate?

"Conditions such as hypotension, unresponsive bradycardia, and anisocoria can all be remedied by this proposed intervention."

Answered by AI

Are there any available vacancies for participants in this experiment?

"According to the latest information on clinicaltrials.gov, this study is no longer recruiting patients. Although the study is no longer active, there are 105 other trials that are currently looking for candidates."

Answered by AI

How many people are allowed to enroll in this research project?

"Unfortunately, this study has already completed recruitment for participants. The listing was first posted on 2023-01-01 but was last edited on 2022-08-15. Although this trial is no longer enrolling patients, there are currently 73 other trials actively recruiting patients with anti-arrhythmia agents and 32 trials for this treatment actively searching for patients."

Answered by AI

Can you share if this current study builds off of any previous research?

"At the moment, there are 32 clinical trials underway for this intervention, with 5 of them in Phase 3. Although a few of the research studies are based in San Diego, California, there are 51 total locations running trials for this intervention."

Answered by AI

Are the participants in this trial restricted to adults over 18?

"In order to participate in this research, enrollees must be between 1 day to 17 years old. There are currently 16 trials underway for patients that meet this age requirement and 93 for patients that are over 65."

Answered by AI

How can I become a part of this experiment?

"Anti-arrhythmia agents are a pre-requisite for potential participants of this study, who must also fall in the age range of 1 day to 17. So far, the trial has recruited 76 individuals."

Answered by AI
~189 spots leftby Jan 2028