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NCT05327556 · ClinicalTrials.gov registry record · Phase 2
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial
A Phase 2 study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT05327556: Clinical Trial Phase 2 study, sponsored by Boston Children's Hospital.
NCT05327556 is a Phase 2 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327556, a Phase 2 study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
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.
Primary Outcome
The change in SBP from the nadir SBP prior to study drug administration to the peak SBP after study drug. The nadir SBP was defined as the lowest measurement within the 5 minutes prior to or up to 1 minute after the documented time of study drug. The peak SBP was the highest measurement with 5 minutes following study drug occurring after the nadir SBP. If an additional dose of epinephrine was administered within 5 minutes of the initial dose, the timeframe was truncated so that the peak SBP was
Interventions
- DRUG Epinephrine 0.5 mcg/kg
- DRUG Epinephrine 1 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2025-05-16 |
| Phase | Phase 2 |
Why NCT05327556 stopped before completion
NCT05327556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Epinephrine 0.5 mcg/kg is the first listed.
NCT05327556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05327556 about?
NCT05327556 is a clinical study titled "Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial". 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 ...
What is the current status of trial NCT05327556?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-02-08. Estimated completion is 2025-05-16.
What interventions are being tested in trial NCT05327556?
The interventions under investigation include: Epinephrine 0.5 mcg/kg (DRUG), Epinephrine 1 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT05327556?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05327556's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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