POHCA Resuscitation: Evaluation of IM Epinephrine

NCT05166343 | Recruiting Phase 2 DMC

• 1 other identifier: PRIME-1
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster quasi randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).

Conditions

Pediatric Out-of-Hospital Cardiac Arrest

Keywords

cardiac arrest; IM Epinephrine; standard of care; pediatric; resuscitation

Outcome Measures

Primary Outcomes (1)

• Time to initial return of spontaneous circulation (ROSC)

  The primary outcome will be the time to initial ROSC. The investigator will compare time to initial ROSC between the standard of care and intervention periods.

  At time of event

Secondary Outcomes (10)

• Return of spontaneous circulation

  At time of event

• Time to sustained ROSC

  At time of event

• Survival

  From time of event to ED admission

• Survival - comparison between both arms

  From time of event to hospital admission

• PCCU/Hospital length of stay

  From time of hospital/PCCU admission to discharge, up to 1 year

Study Arms (2)

Standard of Care

NO 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.

Intramuscular Epinephrine Dose

OTHER

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

Drug: Epinephrine Injection

Interventions

Epinephrine Injection DRUG

Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s) and/or pre-filled syringe (exact dose).

Intramuscular Epinephrine Dose

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 day to and including 17 years experiencing an out-of-hospital cardiac arrest (OHCA)
• Must be receiving at least 1 minute of CPR by trained first responders (police, fire, or paramedic services)

You may not qualify if:

• \- Children who experience OHCA due to an obvious traumatic event.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital - London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Janice Tijssen, MD MSc

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maysaa Assaf

CONTACT

519-685-8500; maysaa.assaf@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc, Interim Director, Paediatric Critical Care

Model Details: Paramedic services across Ontario will participate in the study. All sites will begin with a period of baseline data collection (standard of care arm) and will cross over to the intervention arm (Intramuscular Epinephrine Dose arm) on a staggered schedule and in random order. Each site will remain in the intervention arm, once cross over happens, for the duration of the study.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 21, 2021
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)