Prevention of Delirium in Inpatients Utilizing Melatonin
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.
详细描述
This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.
Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.
Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.
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
- •Inpatient admission to a general internal medicine service
排除标准
- •expected lifespan or length of stay ≤ 48 hours
- •Non-English speaking
- •Already taking melatonin or ramelteon at the time of randomization
- •Presence of delirium at the time of randomization
- •Unable to take oral medications
- •Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission
- •ALT or AST (Liver function tests) > 3 times the upper limit of normal
- •Taking warfarin, nifedipine or fluvoxamine
- •Allergy to melatonin
- •Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday
研究组 & 干预措施
Melatonin
5 mg Melatonin nightly, beginning within 24 hours of admission
干预措施: Melatonin (Drug)
Cellulose Microcrystylline
Blue capsule matching the melatonin arm
干预措施: Placebo (Other)
结局指标
主要结局
Delirium
时间窗: length of hospitalization, not to exceed 14 days
Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization.
次要结局
- Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.(length of hospitalization, not to exceed 14 days)
- Length of Hospital Stay(from day of admission to completion of acute care, not to exceed 30 days)
- Days Utilizing Restraints(length of hospitalization, not to exceed 14 days)