HypotensionPhase 2EPIDoseNCT05327556
Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial
A Phase 2 study testing Epinephrine 0.5 mcg/kg and Epinephrine 1 mcg/kg in people with Hypotension, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Epinephrine 0.5 mcg/kg and Epinephrine 1 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 16 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose)
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.
Read the detailed description
In order to test the hypothesis that PBE doses of 1.0 mcg/kg will have more robust increases in SBP as compared to 0.5 mcg/kg in critically ill children and young adults with acute hypotension, we plan to conduct a Phase II, single-center, prospective, randomized, double-blind, dose-effect trial. Children and young adults <26 years of age who, at the discretion of the clinical team, require rescue PBE for life-threatening hypotension and meet inclusion/exclusion criteria will be enrolled. Prior to randomization, our pharmacy team will prepare treatment packets with 3 pre-mixed PBE which will be stocked in the ICUs with either 5 mcg/mL or 10 mcg/mL of epinephrine. Clinicians will be instructed to use 0.1 mL/kg of the experimental syringe for the initial dose, resulting in target doses of 0.5 mcg/kg (Arm 1) or 1 mcg/kg (Arm 2), respectively. Treatment packs will be labeled according to the randomization scheme, and only the pharmacy team will have knowledge of the concentration of epinephrine in each package. Nurses will be instructed to record the exact time of the experimental dose, around which all time-sensitive data will be collected. The clinicians, patients and research team will be blinded to the intervention. We will not restrict any other interventions chosen by the clinical team. Unblinded interim analyses will be performed after the first 6 months of enrollment, and every 12 months thereafter through study completion and reported to the Data and Safety Monitoring Board (DSMB).
- Conditions
- Hypotension
- Being tested
- Epinephrine 0.5 mcg/kg, Epinephrine 1 mcg/kg
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine 0.5 mcg/kgDrug
Also called Peri-Arrest Bolus Epinephrine
Syringe with 5 mcg/mL epinephrine
Epinephrine 1 mcg/kgDrug
Also called Peri-Arrest Bolus Epinephrine
Syringe with 10 mcg/mL epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mcg/kg Dose | Active comparator | Providers use 0.1 mL/kg of 5 mcg/mL epinephrine for target dose 0.5 mcg/kg Receives: Drug: Epinephrine 0.5 mcg/kg |
| 1.0 mcg/kg Dose | Active comparator | Providers use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg Receives: Drug: Epinephrine 1 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
The change in SBP from the nadir SBP prior to study drug administration to the peak SBP after study drug. The nadir SBP was defined as the lowest measurement within the 5 minutes prior to or up to 1 minute after the documented time of study drug. The peak SBP was the highest measurement with 5 minutes following study drug occurring after the nadir SBP. If an additional dose of epinephrine was administered within 5 minutes of the initial dose, the timeframe was truncated so that the peak SBP was the highest value recorded prior to the subsequent epinephrine dose.
Measured: 5 minutes prior to study drug through 5 minutes after study drug
Secondary outcomes (1)
Incidence of Severe (Stage II) Hypertension
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.
Measured: 5 minutes after study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start8 Feb 2023
- Primary completion16 May 2025
- Study completion16 May 2025
Why it stopped: Funding constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Catherine E. Ross, MD, Boston Children's Hospital
- Investigators
- Catherine E Ross, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327556
- Sponsor's protocol ID
- P00035730
- Other IDs
- K23HL148312
- Acronym
- EPIDose
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2022
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified individual participant data collected during the trial.
Publications
Ross CE, Asaro LA, Wypij D, Holland CC, Donnino MW, Kleinman ME. Physiologic response to pre-arrest bolus dilute epinephrine in the pediatric intensive care unit. Resuscitation. 2018 May;126:137-142. doi: 10.1016/j.resuscitation.2018.03.011. Epub 2018 Mar 8.
PubMed 29526678
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose)
- ClinicalTrials.gov ID
- NCT05327556
- Acronym / sponsor ID
- EPIDose / P00035730
- Conditions
- Hypotension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding constraints
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to test the hypothesis that PBE doses of 1.0 mcg/kg will have more robust increases in SBP as compared to 0.5 mcg/kg in critically ill children and young adults with acute hypotension, we plan to conduct a Phase II, single-center, prospective, randomized, double-blind, dose-effect trial. Children and young adults <26 years of age who, at the discretion of the clinical team, require rescue PBE for life-threatening hypotension and meet inclusion/exclusion criteria will be enrolled. Prior to randomization, our pharmacy team will prepare treatment packets with 3 pre-mixed PBE which will be stocked in the ICUs with either 5 mcg/mL or 10 mcg/mL of epinephrine. Clinicians will be instructed to use 0.1 mL/kg of the experimental syringe for the initial dose, resulting in target doses of 0.5 mcg/kg (Arm 1) or 1 mcg/kg (Arm 2), respectively. Treatment packs will be labeled according to the randomization scheme, and only the pharmacy team will have knowledge of the concentration of epinephrine in each package. Nurses will be instructed to record the exact time of the experimental dose, around which all time-sensitive data will be collected. The clinicians, patients and research team will be blinded to the intervention. We will not restrict any other interventions chosen by the clinical team. Unblinded interim analyses will be performed after the first 6 months of enrollment, and every 12 months thereafter through study completion and reported to the Data and Safety Monitoring Board (DSMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mcg/kg Dose | Active comparator | Drug: Epinephrine 0.5 mcg/kgProviders use 0.1 mL/kg of 5 mcg/mL epinephrine for target dose 0.5 mcg/kg |
| 1.0 mcg/kg Dose | Active comparator | Drug: Epinephrine 1 mcg/kgProviders use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine 0.5 mcg/kgAlso: Peri-Arrest Bolus EpinephrineSyringe with 5 mcg/mL epinephrine | Drug | 0.5 mcg/kg Dose |
| Epinephrine 1 mcg/kgAlso: Peri-Arrest Bolus EpinephrineSyringe with 10 mcg/mL epinephrine | Drug | 1.0 mcg/kg Dose |
Primary outcome
Change in Systolic Blood Pressure
Time frame: 5 minutes prior to study drug through 5 minutes after study drug
The change in SBP from the nadir SBP prior to study drug administration to the peak SBP after study drug. The nadir SBP was defined as the lowest measurement within the 5 minutes prior to or up to 1 minute after the documented time of study drug. The peak SBP was the highest measurement with 5 minutes following study drug occurring after the nadir SBP. If an additional dose of epinephrine was administered within 5 minutes of the initial dose, the timeframe was truncated so that the peak SBP was the highest value recorded prior to the subsequent epinephrine dose.
1 secondary outcome
Incidence of Severe (Stage II) Hypertension
Time frame: 5 minutes after study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29526678Ross CE, Asaro LA, Wypij D, Holland CC, Donnino MW, Kleinman ME. Physiologic response to pre-arrest bolus dilute epinephrine in the pediatric intensive care unit. Resuscitation. 2018 May;126:137-142. doi: 10.1016/j.resuscitation.2018.03.011. Epub 2018 Mar 8.
- Individual participant dataSharing planned: Yes. All deidentified individual participant data collected during the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine E Ross, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epinephrine 0.5 mcg/kg and Epinephrine 1 mcg/kg in people with Hypotension, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (time frame: 5 minutes prior to study drug through 5 minutes after study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.