NCT03431077已完成2 期
An Open-Label, Multi-Center Study of LJPC-501 in Pediatric Patients Who Remain Hypotensive Despite Receiving Fluid Therapy and Vasopressor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Effect of LJPC-501 on mean arterial pressure (MAP)
研究概览
简要总结
The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients 2-17 years of age.
- •Patients requiring a total sum NE equivalent dose of > 0.1 μg/kg/min for a minimum of 2 hours and a maximum of 48 hours prior to initiation of LJPC-501 dosing.
- •Patients must have clinical diagnosis of distributive shock in the opinion of the treating team and the Investigator.
- •Patients are required to have central venous access, which is expected to remain present for the duration of LJPC-501 treatment.
- •Patients are required to have an indwelling arterial line, which is expected to remain present for at least the first 24 hours of LJPC-501 treatment.
- •Patients must have received at least 40 mL/kg of crystalloid or colloid equivalent over the initial 24-hour resuscitation period, and are adequately volume resuscitated in the opinion of the Investigator.
- •Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.
排除标准
- •Patients who are < 2 years of age or ≥ 18 years of age.
- •Patients with a standing Do Not Resuscitate order.
- •Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
- •Patients on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO).
- •Patients who have been on veno-venous (VV) ECMO for less than 6 hours.
- •Patients with a clinical suspicion of cardiogenic shock.
- •Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
- •Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
- •Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
- •Patients with active bleeding AND hemoglobin < 7 g/dL or any other condition that would contraindicate serial blood sampling.
- •Patients with an absolute neutrophil count (ANC) of < 500 cells/mm
- •Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- •Patients with an expected lifespan of < 12 hours or withdrawal of life support within 24 hours of Screening.
- •Patients with a known allergy to mannitol.
- •Patients who are currently participating in another investigational clinical trial.
- •Patients of childbearing potential who are known to be pregnant at the time of Screening.
研究组 & 干预措施
LJPC-501
Experimental
Angiotensin II administered via continuous infusion (1.25 - 40 ng/kg/min) for 24 hours up to 168 hours.
干预措施: Angiotensin II (Drug)
结局指标
主要结局
Effect of LJPC-501 on mean arterial pressure (MAP)
时间窗: 2 hours
To evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP).
Effect of LJPC-501 on sum norepinephrine (NE) equivalent dose
时间窗: 2 hours
To evaluate the effect of LJPC-501 in the reduction of the sum norepinephrine (NE) equivalent dosing.
次要结局
- Effect of LJPC-501 on the incidence of treatment-emergent adverse events(Day 7)
- Effect of LJPC-501 on mean arterial pressure (MAP)(24 hours)
- Effect of LJPC-501 on Pediatric Logistic Organ Dysfunction (PELOD)(24 hours)
- Effect of LJPC-501 on clinical chemistry laboratory parameters(24 hours)
- Effect of LJPC-501 on hematology laboratory parameters(24 hours)
- Effect of LJPC-501 on heart rate(Day 7)
- Effect of LJPC-501 on body temperature(Hour 24)
- Effect of LJPC-501 on general health(Day 7)
- Effect of LJPC-501 on electrical activity of the heart(Hour 24)
- Effect of LJPC-501 on urine output(Day 7)
- Effect of LJPC-501 on serum lactate(2 hours and 24 hours)
- Effect of LJPC-501 on blood pressure(Day 7)
研究者
研究点 (1)
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