ACTRN12615000819527已完成2 期
The Healthy Heart-Mind Trial: Efficacy of melatonin versus placebo for decreasing the incidence and severity of delirium following cardiac surgery in adults
niversity of Western Australia0 个研究点目标入组 210 人开始时间: 2015年8月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
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
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Aged 50 years and older
- •2. Undergoing elective or semi-elective cardiac surgery (on or off cardiopulmonary bypass) for coronary artery bypass grafting (CABG) and/or valvular surgery
排除标准
- •1. Decline or are unable to give informed consent
- •2. Are undergoing emergency surgery
- •3. Are not fluent in written or spoken English (for the purposes of being able to complete the study assessments and questionnaires)
- •4. Have a contraindication to taking melatonin, such as a prior allergic reaction
- •5. Are currently using melatonin
- •6. Have a diagnosis of dementia or score 19 or less on the Telephone Interview for Cognitive Status
- •7. Score 15 or greater on the alcohol use disorders identification test (AUDIT)
研究者
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