Status:
TERMINATED
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial
Lead Sponsor:
Boston Children's Hospital
Conditions:
Hypotension
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
Brief 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...
Detailed Description
In order to test the hypothesis that PBE doses of 1.0 mcg/kg will have more robust increases in SBP as compared to 0.5 mcg/kg in critically ill children and young adults with acute hypotension, we pla...
Eligibility Criteria
Inclusion
- Male or female less than 26 years of age.
- Admitted to BCH and receiving care in a participating ICU.
- Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician.
Exclusion
- Has opted out of the study prior to enrollment.
- Has orders in place which limit resuscitation efforts.
- Is actively receiving chest compressions while PBE is administered.
- Is receiving care in the neonatal intensive care unit.
- Is receiving care outside of the ICU at the time PBE is administered (i.e procedural areas).
- Is pregnant or breastfeeding.
- Is a prisoner.
- Is a ward if the state (DCF custody).
Key Trial Info
Start Date :
February 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05327556
Start Date
February 8 2023
End Date
May 16 2025
Last Update
August 22 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115