PRIME: POHCA Resuscitation: Evaluation of IM Epinephrine

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05166343

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Out-of-Hospital Cardiac Arrest	Drug: Epinephrine Injection	Phase 2/Phase 3

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 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 in POHCA.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Pediatric Out-of-Hospital Cardiac Arrest Resuscitation: Evaluation of IM Epinephrine (The PRIME Trial)

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight.
Other: Intramuscular Epinephrine Dose POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector. Dosing will be dependent on weight as follows: 3-<5kg=0.3mg IM epinephrine 5-<10kg=0.5mg IM epinephrine 10-<25kg=1.0mg IM epinephrine 25kg=1.5mg IM epinephrine	Drug: Epinephrine Injection Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s)

Arm

Intervention/Treatment

No Intervention: Standard of Care

All POHCA events will be handled per standard of care of epinephrine administration via intravenous or intraosseous (IV/IO) based on patient estimated weight.

Other: Intramuscular Epinephrine Dose

POHCA events will be handled per standard of care, however, first dose epinephrine administration will be via intramuscular (IM) autoinjector. Dosing will be dependent on weight as follows: 3-<5kg=0.3mg IM epinephrine 5-<10kg=0.5mg IM epinephrine 10-<25kg=1.0mg IM epinephrine 25kg=1.5mg IM epinephrine

Drug: Epinephrine Injection

Epinephrine administered via sterile epinephrine injection USP, by 0.3mg or 0.5mg epinephrine auto-injector(s)

Outcome Measures

Primary Outcome Measures

Time to initial return of spontaneous circulation (ROSC) [At time of event]
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.

Secondary Outcome Measures

Return of spontaneous circulation [At time of event]
Whether return of spontaneous circulation is achieved or not
Time to sustained ROSC [At time of event]
Time to sustained ROSC will be calculated from the time that paramedics arrive on scene to the time that sustained ROSC, defined as chest compressions not required for 20 minutes with persistent signs of circulation, is achieved.
Survival [From time of event to ED admission]
Survival to emergency department transfer to pediatric critical care unit (PCCU), if applicable: admitted to PCCU from external ED
Survival - comparison between both arms [From time of event to hospital admission]
Survival to hospital admission will be compared between standard of care and intervention periods
PCCU/Hospital length of stay [From time of hospital/PCCU admission to discharge, up to 1 year]
PCCU and hospital length of stay will be calculated from time of admission to the PCCU/hospital and time to discharge from PCCU/hospital, if applicable, between standard of care and intervention periods
Survival to hospital discharge [Dependent on course of hospital stay, up to 1 year]
Survival to hospital discharge will be compared between standard of care and intervention periods
Post POHCA survival [Dependent on survival at 6 and 12 month period post POHCA event]
Survival at 6 months and 12 months post-POHCA will be compared between standard of care and intervention periods
Neurological status [From time of discharge and 6 and 12 months post POHCA event]
The investigator will compare PCPC scores at discharge, 6- and 12-months post-POHCA between the standard of care and intervention periods
Life Impact and Pediatric Quality of Life assessments [6 and 12 months post POHCA event]
Life Impact assessment between 6 and 12 months: the investigator will use the Pediatric Quality of Life (PEDSQoL, Pediatrics Quality of Life) assessment tool at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. The score ranges from 0-100, with higher scores indicating better outcome.
Life Impact and Pediatric Quality of Life assessments [6 and 12 months post POHCA event]
Life Impact assessment between 6 and 12 months: the investigator will use the Daily Activities Scale at 6- and 12-months post-POHCA in all survivors and compare between standard of care and intervention periods. This scale is a subscore of the PEDSQoL tool with scores ranging from 0-100, with higher scores indicating better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)