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

NCT05327556 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Epinephrine 0.5 mcg/kg

Syringe with 5 mcg/mL epinephrine

DRUG

Epinephrine 1 mcg/kg

Syringe with 10 mcg/mL epinephrine

Sponsors & Collaborators

Principal Investigators

  • Catherine E Ross, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2025-05-16
Completion
2025-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327556 on ClinicalTrials.gov