NCT00592488已完成1 期
Prospective, Randomized, Placebo-controlled, Double-Blinded, Phase II Pilot Study of Acetyl-L-carnitine in the Treatment of Patients With Septic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Mean Arterial Blood Pressure
研究概览
简要总结
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.
详细描述
This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented or presumed infection
- •shock requiring vasopressors
排除标准
- •hepatic failure
研究组 & 干预措施
A
Other
Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours
干预措施: Acetyl-L-Carnitine (Drug)
B
Other
Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
干预措施: Acetyl-L-Carnitine (Drug)
结局指标
主要结局
Mean Arterial Blood Pressure
时间窗: 18 hours
Mean Arterial blood pressure measured non-invasively at 18 hours
次要结局
- Vasopressor Dose(6-24 hours)
- Serum Lactate(12-36 hours)
研究者
Todd Rice
Assistant Professor
Vanderbilt University
研究点 (1)
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