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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)

Must not have

Children who experience OHCA due to an obvious traumatic event

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dependent on course of hospital stay, up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I received CPR from a trained responder for at least 1 minute.

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My child, aged 17 or younger, had a cardiac arrest outside of a hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child had a cardiac arrest due to a clear injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dependent on course of hospital stay, up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to initial return of spontaneous circulation (ROSC)

Secondary study objectives

Life Impact and Pediatric Quality of Life assessments

Neurological status

PCCU/Hospital length of stay

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epinephrine Injection

2024

Completed Phase 2

~40

0 / 3Eligibility criteria met