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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

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).