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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

Awards & highlights

EPIDose Trial 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.

EPIDose Trial 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.

EPIDose Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

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

EPIDose 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,644 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial encompass participants of all ages, or are there restrictions concerning those who may enroll?

"As indicated by the inclusion criteria, this trial is only open to participants aged 0-25. There are 7 studies that accept minors while 88 specifically target seniors over 65 years old."

Answered by AI

Are there opportunities to join this medical research experiment?

"Clinical trials.gov confirms that this clinical trial is no longer in recruitment mode; it was initially posted on February 1st 2023 and edited for the last time on the same date. Nonetheless, there are still 112 other medical studies actively seeking volunteers at present."

Answered by AI

Has the Federal Drug Administration certified 0.5 mcg/kg Dose as safe and effective?

"Based on our assessment, the safety of 0.5 mcg/kg Dose ranks at a 2 due to only limited evidence from Phase 2 trials which acknowledges its relative security but does not validate its efficacy."

Answered by AI

Am I eligibile to contribute data for this research endeavor?

"This trial is actively seeking 86 individuals aged 0-25 with low blood pressure. The eligibility criteria for this project include the following: a person of either gender, younger than 26 years old, prescribed BDE to manage acute hypotension deemed life threatening by their clinician, and admitted to an ICU in Boston Children's Hospital (BCH)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial

Catherine E. Ross, MD 2023. "Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327556.