jRCTs041200112已完成不适用
Preventive effect of ramelteon on delirium in ICU
未提供0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •ICU patients 18 years old or more, expected to stay in ICU for over 48 hours.
- •Patients registered within 48hours of ICU admission and administrated first medication on the registration day.
排除标准
- •Patients under 18 years old.
- •Allergy to ramelteon.
- •Patients with severe liver injury (T-Bil >= 10 mg/dL, or ALT >= 750 IU/L).
- •Patients receiving fluvoxamine maleate.
- •Patients already receiving ramelteon therapy before admission.
- •Patients expected to leave ICU within 48 hours of admission.
- •Patients expected to die within 48 hours of admission or be excluded from active treatment.
- •Pregnant or lactating women.
- •Patients expected to be difficult to evaluate delirium by CAM-ICU due to neurological problems such as post-cardiac arreest, head trauma, stroke, or other illness.
- •Absence of written informed consent.
结局指标
主要结局
-
Occurrence of ICU-delirium
次要结局
- Ventilator free days(Day 1 to day 28)
研究者
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