NCT02297763Unknown3 期
Prophylactic Quetiapine on Delirium Prevention in Critically Ill Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 194
- 主要终点
- Development of delirium within 14 days after admitting to ICU (Rate)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of low dose quetiapine for the prophylaxis of delirium in critically ill patients in medical intensive care unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 19 years of age, admitting to medical ICU, anticipated to stay more than 72hours
排除标准
- •Female patients who are pregnant or breastfeeding
- •active delirium
- •Received other anti-psychotic drug before attend the study
- •severe bradycardia
- •alcohol intoxication
- •No written consent from the legal representatives
- •Being ill with renal or hepatic failure
研究组 & 干预措施
quetiapine
Active Comparator
quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form.
干预措施: quetiapine (Drug)
placebo
Placebo Comparator
The placebo is made of 100mg of corn starch which is melted in 10cc water.
干预措施: placebo (Drug)
结局指标
主要结局
Development of delirium within 14 days after admitting to ICU (Rate)
时间窗: 14 days after admitting to intensive care unit
次要结局
- Duration of delirium occurring within 14 days after admitting to ICU (Days)(14 days after admitting to ICU)
- Length of stay in ICU and hospital (Days)(up to 24 weeks)
- 60 days in hospital mortality (Rate)(60 days after admitting to ICU)
- Duration of mechanical ventilation in ICU (Days)(14days after admitting to intensive care unit)
研究者
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