Clinical trial NCT05166343: POHCA Resuscitation: Evaluation of IM Epinephrine
Official title: Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pediatric Out-of-Hospital Cardiac Arrest
Keywords: cardiac arrest
IM Epinephrine
standard of care
pediatric
resuscitation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 284
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: IM epinephrine may provide a more efficient means of administering the initial epinephrine dose (versus IV/IO administration) to a child experiencing pediatric out of hospital cardiac arrest (POHCA) with no greater risk of harm. In so doing, this may improve the short- and long-term outcomes of these patients. There is an abundance of literature detailing the risk/benefit profile of IM epinephrine use in anaphylaxis; however, there is no human data on this topic as it relates to cardiac arrest. Important knowledge gaps include whether the use of IM epinephrine via autoinjector and/or pre-filled syringe leads to faster administration of the initial doses of epinephrine without delaying time to definitive epinephrine (via IV/IO) and the impact on time to initial and sustained return of spontaneous circulation (ROSC). This trial will be the first to examine the role of IM epinephrine via autoinjector/pre-filled syringe in POHCA.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Time to initial return of spontaneous circulation (ROSC)
timeFrame: At time of event
Secondary outcomes:
measure: Return of spontaneous circulation
timeFrame: At time of event
measure: Time to sustained ROSC
timeFrame: At time of event
measure: Survival
timeFrame: From time of event to ED admission
measure: Survival - comparison between both arms
timeFrame: From time of event to hospital admission
measure: PCCU/Hospital length of stay
timeFrame: From time of hospital/PCCU admission to discharge, up to 1 year
measure: Survival to hospital discharge
timeFrame: Dependent on course of hospital stay, up to 1 year
measure: Post POHCA survival
timeFrame: Dependent on survival at 6 and 12 month period post POHCA event
measure: Neurological status
timeFrame: From time of discharge and 6 and 12 months post POHCA event
measure: Life Impact and Pediatric Quality of Life assessments
timeFrame: 6 and 12 months post POHCA event
measure: Life Impact and Pediatric Quality of Life assessments
timeFrame: 6 and 12 months post POHCA event
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Hospital - London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Janice Tijssen, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: