Epinephrine Dosing for Low Blood Pressure in Children
(EPIDose Trial)
What You Need to Know Before You Apply
What is the purpose of this 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 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is epinephrine safe for use in children?
Epinephrine is generally considered safe for use in children, especially in emergency situations like anaphylaxis (severe allergic reaction) and low blood pressure. It is commonly used in the form of auto-injectors for allergic reactions, and any side effects are usually mild and temporary compared to the risks of not using it.12345
How is the drug epinephrine unique for treating low blood pressure in children?
Epinephrine is unique for treating low blood pressure in children because it can be administered in low-dose boluses, which is different from the standard-dose used in other emergency situations like cardiac arrest. This approach is tailored to critically ill children experiencing acute hypotension (low blood pressure), providing a more controlled and potentially safer method of administration.13456
What data supports the effectiveness of the drug epinephrine for treating low blood pressure in children?
Research shows that using frequent doses of epinephrine during pediatric cardiac arrest is linked to better survival rates and improved brain function outcomes. Additionally, low-dose epinephrine boluses have been used effectively in critically ill children experiencing sudden low blood pressure.14578
Who Is on the Research Team?
Catherine E Ross, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive peri-arrest bolus epinephrine (PBE) at doses of 0.5 mcg/kg or 1.0 mcg/kg to assess hemodynamic outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including survival to hospital discharge and incidence of adverse events
Safety Monitoring
Unblinded interim analyses performed to assess safety outcomes and reported to the Data and Safety Monitoring Board (DSMB)
What Are the Treatments Tested in This Trial?
Interventions
- Epinephrine
Epinephrine is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor