Prospective, Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Intravenous Citrulline to Prevent or Mitigate Acute Lung Injury in Patients With Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Vasopressor Dependency Index
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis is that intravenous L-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Sepsis
排除标准
- •No Consent
- •Malignant or other irreversible condition
- •Moribund and not expected to survive 48 hours
- •End Stage Liver Disease
- •Enrolled in another IND study
- •Pregnant or breast feeding female
- •Age<13 years old
- •Allergy to citrulline or arginine
研究组 & 干预措施
Low Dose Citrulline
Low Dose Citrulline
干预措施: Low Dose Citrulline (Drug)
Placebo
Placebo IV infusion
干预措施: Placebo (Drug)
High Dose Citrulline
High Dose Citrulline
干预措施: High Dose Citrulline (Drug)
结局指标
主要结局
Vasopressor Dependency Index
时间窗: day 4
Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)
次要结局
未报告次要终点
研究者
Todd Rice
Assistant Professor of Medicine
Vanderbilt University