Hypotension
Conditions
Brief 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. 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).
Interventions
DRUGEpinephrine 0.5 mcg/kg
Syringe with 5 mcg/mL epinephrine
DRUGEpinephrine 1 mcg/kg
Syringe with 10 mcg/mL epinephrine
Sponsors
Boston Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Study kits in either arm will be identical, and only the research pharmacy and the study statisticians will have access to the populated Master Randomization List.
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female less than 26 years of age. 2. Admitted to BCH and receiving care in a participating ICU. 3. Is prescribed BDE for acute hypotension deemed to be life-threatening in the judgement of the treating clinician.
Exclusion criteria
1. Has opted out of the study prior to enrollment. 2. Has orders in place which limit resuscitation efforts. 3. Is actively receiving chest compressions while PBE is administered. 4. Is receiving care in the neonatal intensive care unit. 5. Is receiving care outside of the ICU at the time PBE is administered (i.e procedural areas). 6. Is pregnant or breastfeeding. 7. Is a prisoner. 8. Is a ward if the state (DCF custody).
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine E Ross, MD
Boston Children's Hospital
Outcome results
None listed