NCT03402113Unknown不适用
The Effect of Different Sedation Protocols on Skeletal Muscle Metabolism in Mechanical Ventilated Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- acute muscle wasting
研究概览
简要总结
To investigate the effects of different sedation protocols on skeletal muscle metabolism in mechanical ventilated patients in ICU. Mechanical ventilated patients who are anticipated to stay in ICU for more than 5 days are enrolled and randomly assigned to the following three groups, interventional group(dexmedetomidine), control group(midazolam) and no sedation group. Serum, CT scan of intercostal muscles, ultrasound evaluation of quadriceps femoris are obtained.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanical ventilated for more than 48h
- •18-80 years
- •stay in ICU for more than 5 days
- •Exclusion Criteria
- •already participated in other clinical trials
- •pregnancy or lactation
- •lower limb amputation
- •primary neuro-muscular disease
- •disseminated tumor or accepted special therapy
- •alcohol abuse
- •severe liver dysfunction(Child-Push C)
- •unstable angina/acute myocardial infarction
- •heart rates<50bpm
- •all kinds dialysis
- •severe burn
- •epidural anesthesia
- •severe neurological disease（acute stroke, uncontrollable epilepsy, severe dementia, etc）
排除标准
- 未提供
研究组 & 干预措施
Dexmedetomidine group
Experimental
Dexmedetomidine consistent infusion as sedative.
干预措施: Dexmedetomidine (Drug)
Midazolam group
Active Comparator
Midazolam consistent infusion as sedative.
干预措施: Midazolam (Drug)
结局指标
主要结局
acute muscle wasting
时间窗: From date of randomization to extubation,up to 7 days
measured by 3-MH release in serum
次要结局
- 28-day mortality(From date of randomization to date of death from any cause,up to 28 days)
- length of ICU stay(From date of randomization to date of to discharge or death,up to 28 days)
研究者
研究点 (1)
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