Epinephrine in the Pediatric Intensive Care Unit: A Dose-Effect Trial (EPI Dose)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
1.0 mcg/kg Dose
Providers use 0.1 mL/kg of 10 mcg/mL epinephrine for target dose of 1.0 mcg/kg
干预措施: Epinephrine 1 mcg/kg (Drug)
0.5 mcg/kg Dose
Providers use 0.1 mL/kg of 5 mcg/mL epinephrine for target dose 0.5 mcg/kg
干预措施: Epinephrine 0.5 mcg/kg (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: 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.
次要结局
- Incidence of Severe (Stage II) Hypertension(5 minutes)
研究者
Catherine E. Ross, MD
Attending Physician
Boston Children's Hospital