- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327556
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPIDose)
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female less than 26 years of age.
- Admitted to BCH and receiving care in a participating ICU.
- Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician.
Exclusion Criteria:
- Has opted out of the study prior to enrollment.
- Has orders in place which limit resuscitation efforts.
- Is actively receiving chest compressions while PBE is administered.
- Is receiving care in the neonatal intensive care unit.
- Is receiving care outside of the ICU at the time PBE is administered (i.e procedural areas).
- Is pregnant or breastfeeding.
- Is a prisoner.
- Is a ward if the state (DCF custody).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 0.5 mcg/kg Dose
Providers use 0.1 mL/kg of 5 mcg/mL epinephrine for target dose 0.5 mcg/kg
|
Syringe with 5 mcg/mL epinephrine
Other Names:
|
Active Comparator: 1.0 mcg/kg Dose
Providers use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg
|
Syringe with 10 mcg/mL epinephrine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Systolic Blood Pressure
Time Frame: 10 minutes
|
The lowest systolic blood pressure value in the 5 minutes prior to or up to 1 minute after the documented time of PBE administration (nadir) subtracted from the highest systolic blood pressure in the 5 minutes following PBE (must be subsequent to the nadir). If an additional dose of PBE was administered within 5 minutes of the initial dose, the peak SBP will be the highest value recorded prior to the subsequent dose. Primary analysis will be performed with an intention-to-treat approach based on the concentration of study drug received. An exploratory analysis will be performed per protocol based on the actual volume of study drug the patient received on first administration being within 20% of the intended volume. Patients who received ≥0.4 to ≤0.6 mcg/kg will be considered in the 0.5 mcg/kg group whereas patients who received ≥0.8 to ≤1.2 mcg/kg will be considered in the 1 mcg/kg group. |
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Severe (Stage II) Hypertension
Time Frame: 5 minutes
|
The proportion of patients whose peak systolic blood pressure (determined as per the primary outcome) is greater than or equal to the 95th percentile plus 12 mmHg or greater than or equal to 140 mmHg, whichever is lower.
|
5 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Cardiac Arrest
Time Frame: 0 to 120 minutes
|
The proportion of patients who receive chest compressions at anytime from 0 to 120 minutes after the first dose of study drug
|
0 to 120 minutes
|
Incidence of Extra-corporeal Membrane Oxygenation (ECMO)
Time Frame: 0 to 120 minutes
|
The proportion of patients who are cannulated to ECMO at anytime from 0 to 120 minutes after the first dose of study drug, starting at time of first flow
|
0 to 120 minutes
|
Early Survival
Time Frame: 7 days
|
The proportion of patients alive or discharged from the hospital alive at 7 days after the calendar day study drug was administered
|
7 days
|
Survival to Hospital Discharge
Time Frame: 90 days
|
The proportion of patients alive at time of discharge from the hospital (Truncated at 90 days)
|
90 days
|
Change in Heart Rate (HR)
Time Frame: 10 minutes
|
Difference in HR before and after PBE is given, using measurements that coincide with the primary outcome
|
10 minutes
|
Change in Mean Arterial Pressure (MAP)
Time Frame: 10 minutes
|
Difference in MAP before and after PBE is given, using measurements that coincide with the primary outcome
|
10 minutes
|
Change in Diastolic Blood Pressure (DBP)
Time Frame: 10 minutes
|
Difference in DBP before and after PBE is given, using measurements that coincide with the primary outcome
|
10 minutes
|
Percent Change in Vital Signs
Time Frame: 10 minutes
|
The difference in SBP, MAP, DBP and HR (defined as above) expressed as a percentage.
|
10 minutes
|
Incidence of Stage I Hypertension (or greater)
Time Frame: 5 minutes
|
The proportion of patients whose peak systolic blood pressure (as per the primary outcome) is greater than or equal to the 95th percentile or 130/80 mm Hg (whichever is lower).
|
5 minutes
|
Incidence of Extreme Hypertension
Time Frame: 5 minutes
|
The proportion of patients whose peak systolic blood pressure (as per the primary outcome) is greater than or equal to the 95th percentile + 30 mm Hg or ≥170, whichever is lower.
|
5 minutes
|
Incidence of Non-Responders
Time Frame: 10 minutes
|
The proportion of patients who do not respond to initial dose of study drug, defined as <10mmHg difference between nadir and peak SBP
|
10 minutes
|
Number of doses of epinephrine per resuscitation episode
Time Frame: 120 minutes
|
Comparison of the number of doses of epinephrine (study drug or open label) given in a discrete resuscitation episode up to 120 minutes after initial dose.
|
120 minutes
|
Total dose of epinephrine per resuscitation episode
Time Frame: 120 minutes
|
Comparison of the total dose of epinephrine (study drug or open label) in mcg/kg given in a discrete resuscitation episode up to 120 minutes after initial dose.
|
120 minutes
|
Safety Outcomes
Time Frame: 0 to 7 days
|
The proportion of patients who develop the following prespecified safety outcomes:
|
0 to 7 days
|
Continuous Dose Effect Curve
Time Frame: 10 minutes
|
Correlation of actual dose received in mcg/kg with change in systolic blood pressure.
|
10 minutes
|
Effect on change in Systolic Blood Pressure by treatment group
Time Frame: 10 minutes
|
Effect on change in Systolic Blood Pressure by treatment group controlling for:
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine E Ross, MD, Boston Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- P00035730
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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