Clinical trial

Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose)

Name
P00035730
Description
The use of peri-arrest bolus epinephrine (PBE) has emerged as a rescue strategy for life-threatening hypotension in pediatric intensive care units (ICU) despite scant published data supporting its use in this setting. As optimal dosing of PBE in this population is unclear, we aim to determine if an initial dose of 0.5 mcg/kg versus 1.0 mcg/kg yields differences in hemodynamic outcomes. The EPI Dose Study is a single-center, prospective, randomized, double-blind, dose-effect trial measuring systolic blood pressure (SBP) before and after PBE is given. We hypothesize that the 1.0 mcg/kg group will have more robust increases in SBP.
Trial arms
Trial start
2023-02-08
Estimated PCD
2026-12-01
Trial end
2026-12-01
Phase
Early phase I
Treatment
Epinephrine 0.5 mcg/kg
Syringe with 5 mcg/mL epinephrine
Arms:
0.5 mcg/kg Dose
Other names:
Peri-Arrest Bolus Epinephrine
Epinephrine 1 mcg/kg
Syringe with 10 mcg/mL epinephrine
Arms:
1.0 mcg/kg Dose
Other names:
Peri-Arrest Bolus Epinephrine
Size
86
Primary endpoint
Change in Systolic Blood Pressure
10 minutes
Eligibility criteria
Inclusion Criteria: 1. Male or female less than 26 years of age. 2. Admitted to BCH and receiving care in a participating ICU. 3. Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician. Exclusion Criteria: 1. Has opted out of the study prior to enrollment. 2. Has orders in place which limit resuscitation efforts. 3. Is actively receiving chest compressions while PBE is administered. 4. Is receiving care in the neonatal intensive care unit. 5. Is receiving care outside of the ICU at the time PBE is administered (i.e procedural areas). 6. Is pregnant or breastfeeding. 7. Is a prisoner. 8. Is a ward if the state (DCF custody).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Study kits in either arm will be identical, and only the research pharmacy and the study statisticians will have access to the populated Master Randomization List.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 86, 'type': 'ESTIMATED'}}
Updated at
2024-04-23

1 organization

1 product

1 indication