NCT04014218Unknown4 期
Effect of Inhalation Sedation With Sevoflurane Compared With Propofol on the Sepsis-related Acute Respiratory Distress Syndrome (ARDS) Course.
Moscow Regional Research and Clinical Institute (MONIKI)1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Investigation of effect of inhalation sedation by administration of Sevoflurane compared with Propofol on the moderate acute respiratory distress syndrome course in mechanically ventilated patients with sepsis.
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 (Investigator)
盲法说明
opaque envelopes
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •P/F Ratio 100-250
- •start of mechanical ventilation
排除标准
- •pregnancy
- •concomitant oncological disease
- •prior psychological impairment
研究组 & 干预措施
Inhalation sedation
Experimental
干预措施: Inhalation Sedation (Drug)
Propofol
Active Comparator
干预措施: Intravenous Sedation (Drug)
结局指标
主要结局
mortality
时间窗: 28 days after ICU admission
28 days and in-hospital mortality
ICU Length of stay (LOS)
时间窗: 45 days after ICU admission
Length of stay in ICU
Length of mechanical ventilation (LMV)
时间窗: 45 days after ICU admission
Length of mechanical ventilation
次要结局
- event of RRT(28 days after ICU admission)
- MACCE(28 days after ICU admission)
- P/F Ratio(45 days after ICU admission)
- Delirium(5 days after ICU admission)
研究者
Valery V. Likhvantsev, Professor
Professor, Head of Intensive Care Department Moscow Regional Clinical and Research Institute
Moscow Regional Research and Clinical Institute (MONIKI)
研究点 (1)
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