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?
This trial tests two different doses of epinephrine (also known as adrenaline) to determine which more effectively raises low blood pressure in children in the ICU. Some children experience dangerously low blood pressure, and doctors aim to discover whether a 0.5 mcg/kg dose or a 1.0 mcg/kg dose of epinephrine is more effective. Children in the ICU with life-threatening low blood pressure might be suitable candidates for this trial. The goal is to identify which dose improves blood pressure more effectively and safely. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of children, contributing to important findings.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that epinephrine is often used to help children with very low blood pressure in intensive care units. Studies have found that both low (0.5 mcg/kg) and higher doses (1.0 mcg/kg) of epinephrine effectively raise blood pressure in these cases.
Epinephrine increases blood pressure and urine output, helping to stabilize patients. Although specific side effects for these doses aren't detailed, experts in children's healthcare widely use and accept epinephrine, indicating it is generally well-tolerated. No major safety concerns have been reported for these doses in similar situations.
While ongoing studies will provide more information, the current use of epinephrine in pediatric intensive care suggests it is safe.12345Why are researchers excited about this trial's treatment?
Researchers are excited about the epinephrine dosing protocol for low blood pressure in children because it explores more precise dosing strategies. Unlike standard treatments that often focus on broader dosing ranges, this approach fine-tunes the dosage to either 0.5 mcg/kg or 1.0 mcg/kg, potentially enhancing effectiveness and safety. By targeting specific doses, researchers aim to optimize blood pressure management with fewer side effects, which could be a significant advancement in pediatric care.
What evidence suggests that this trial's treatments could be effective for low blood pressure in children?
Research has shown that epinephrine can help manage low blood pressure, especially in emergencies. One study suggested that epinephrine can quickly raise blood pressure. For children in critical care, early use of epinephrine has shown promise in treating severe low blood pressure. This trial will compare two different dosing regimens of epinephrine: a 0.5 mcg/kg dose and a 1.0 mcg/kg dose. Although some studies have mixed results, evidence indicates that epinephrine can be a key tool for treating dangerously low blood pressure in children. However, its effectiveness can depend on the child's condition and other factors, such as whether they are on a ventilator or have heart issues.46789
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:
- Anaphylaxis
- Cardiac arrest
- Severe allergic reactions
- Anaphylaxis
- Cardiac arrest
- Severe allergic reactions
- Anaphylaxis
- Cardiac arrest
- Severe allergic reactions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor