Epinephrine Dosing for Low Blood Pressure in Children

(EPIDose Trial)

Overseen By Catherine E Ross, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Boston Children's Hospital

Disqualifiers: Pregnancy, Prisoner, DCF custody, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate intervention

86 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 3 5 7 8}

Research Team

Catherine E Ross, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

Admitted to BCH and receiving care in a participating ICU

I am prescribed BDE for life-threatening low blood pressure.

I am under 26 years old.

Exclusion Criteria

My baby is currently in the neonatal intensive care unit.

I am getting chest compressions during PBE treatment.

Is a prisoner

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive peri-arrest bolus epinephrine (PBE) at doses of 0.5 mcg/kg or 1.0 mcg/kg to assess hemodynamic outcomes

Immediate intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survival to hospital discharge and incidence of adverse events

90 days

Safety Monitoring

Unblinded interim analyses performed to assess safety outcomes and reported to the Data and Safety Monitoring Board (DSMB)

Ongoing throughout study

Treatment Details

Interventions

• Epinephrine

Trial Overview 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.

Participant Groups

Group I: 0.5 mcg/kg Dose Active Control 1 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 Dose Active Control 1 Intervention

Providers use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg

Epinephrine is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Epinephrine for:

• Anaphylaxis
• Cardiac arrest
• Severe allergic reactions

Approved in United States as Epinephrine for:

• Anaphylaxis
• Cardiac arrest
• Severe allergic reactions

Approved in Canada as Epinephrine for:

• Anaphylaxis
• Cardiac arrest
• Severe allergic reactions

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-Dose Epinephrine Boluses for Acute Hypotension in the PICU. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Epinephrine Dosing Intervals on Outcomes from Pediatric In-Hospital Cardiac Arrest. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

What dose of epinephrine is being used in pediatric resuscitation? Results of a survey. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Epinephrine dosing strategies during pediatric extracorporeal cardiopulmonary resuscitation reveal novel impacts on survival: A multicenter study utilizing time-stamped epinephrine dosing records. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

What is the right dose of epinephrine? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Self-injectable epinephrine for first-aid management of anaphylaxis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

CSACI position statement: epinephrine auto-injectors and children [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

High dose of epinephrine does not improve survival of children with out-of-hospital cardiac arrest: Results from the French National Cardiac Arrest Registry. [2022]