NCT00871039撤回4 期
Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Stress response and immune function.
研究概览
简要总结
The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.
详细描述
No detailed description
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Diagnosis of alcohol use disorders
- •Need for invasive mechanical ventilation
- •Need for continuous intravenous infusion of sedative(s)
排除标准
- •Age < 18 years
- •Pregnant women
- •Prisoners
- •Receiving propofol prior to randomization
- •Patient experiencing active alcohol withdrawal
- •Immunosuppression
- •Attending physician does not feel patient is candidate to receive either propofol or midazolam
- •Patient has contraindication(s) to receiving either propofol or midazolam
- •Inability to enroll patient within 96 hours after initiation of mechanical ventilation
- •Transfer from another intensive care unit
研究组 & 干预措施
Propofol
Experimental
Patients to be sedated for up to 72 hours with study drug propofol
干预措施: Propofol (Drug)
Midazolam
Experimental
Patients to be sedated for up to 72 hours with study drug midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
Stress response and immune function.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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