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Adrenergic Agonist

Epinephrine Dosing for Low Blood Pressure in Children (EPIDose Trial)

Phase 2
Waitlist Available
Led By Catherine E Ross, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician
Male or female less than 26 years of age
Must not have
Is receiving care in the neonatal intensive care unit
Is actively receiving chest compressions while PBE is administered
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Summary

This trialwill compare two doses of epinephrine to see which is most effective in treating life-threatening hypotension in pediatric ICU patients. We will measure systolic blood pressure to see if the higher dose leads to better results.

Who is the study for?
This trial is for children under 26 years old in a pediatric ICU who need an emergency drug (PBE) for life-threatening low blood pressure. It's not for kids getting CPR, in neonatal care, outside the ICU when PBE is given, or those with limited resuscitation orders.Check my eligibility
What is being tested?
The study tests two doses of epinephrine (0.5 mcg/kg and 1 mcg/kg) to see which works better at raising blood pressure in critically ill kids. Patients are randomly assigned to receive one of the doses without knowing which one they get.See study design
What are the potential side effects?
Possible side effects of epinephrine include rapid heart rate, high blood pressure, tremors, headaches, and feelings of anxiety or restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am prescribed BDE for life-threatening low blood pressure.
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I am under 26 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My baby is currently in the neonatal intensive care unit.
Select...
I am getting chest compressions during PBE treatment.
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I have decided not to participate in this study before joining.
Select...
I am not in the ICU when receiving my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Systolic Blood Pressure
Secondary outcome measures
Incidence of Severe (Stage II) Hypertension
Other outcome measures
Change in Diastolic Blood Pressure (DBP)
Change in Heart Rate (HR)
Change in Mean Arterial Pressure (MAP)
+13 more

Trial Design

2Treatment groups
Active Control
Group I: 0.5 mcg/kg DoseActive Control1 Intervention
Providers use 0.1 mL/kg of 5 mcg/mL epinephrine for target dose 0.5 mcg/kg
Group II: 1.0 mcg/kg DoseActive Control1 Intervention
Providers use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,865 Total Patients Enrolled
Catherine E Ross, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Epinephrine (Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05327556 — Phase 2
Low Blood Pressure Research Study Groups: 0.5 mcg/kg Dose, 1.0 mcg/kg Dose
Low Blood Pressure Clinical Trial 2023: Epinephrine Highlights & Side Effects. Trial Name: NCT05327556 — Phase 2
Epinephrine (Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327556 — Phase 2
~54 spots leftby Dec 2026
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