A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Delirium (Confusion Assessment Method)
研究概览
简要总结
Delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions.
A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. There is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. We hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or greater
- •Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.
排除标准
- •those who are suspected to be delirious at the time of their initial presentation;
- •those who are already taking melatonin prior to admission;
- •those who are not expected to live more than 48 hours;
- •those suffering severe dementia (as indicated by a score of 6-7 on the Global Deterioration Scale adapted by Dr. Doug Drummond from Reisberg et al. (Reisberg 1982);
- •those who are unable to reliably take oral medications;
- •those presenting with an intracranial bleed, seizure or acute stroke;
- •those with a known allergy or adverse reaction to the study compounds;
- •those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate;
- •those anticipated to require surgery early in their hospitalization.
研究组 & 干预措施
Placebo
Patients given once daily placebo (cellulose) orally in the evening, for 14 days.
干预措施: Placebo (Other)
Melatonin
Patients given once daily melatonin 1.5mg orally in the evening, for 14 days.
干预措施: Melatonin (Drug)
结局指标
主要结局
Delirium (Confusion Assessment Method)
时间窗: Within 14 days
Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician.
次要结局
- Mortality(Within 14 days)
- Use of restraints(Within 14 days)
- Confusion (Confusion Assessment Method scores)(Within 14 days)
- Code White (Violence)(Within 14 days)
研究者
Peter Y Chan
Dr. Peter Chan
University of British Columbia