Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Delirium Using the CAM Over Time
研究概览
简要总结
Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population.
The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hip or other long bone fracture undergoing operative repair
- •age of 70 years or older
- •the ability to communicate effectively in English (including adequate hearing)
- •residence within a 50 mile radius of the BIDMC
- •life expectancy 6 months or greater
- •not currently on cholinesterase inhibitor therapy
- •not with known hypersensitivity to cholinesterase inhibitors
- •not a previous study participant or refusal
排除标准
- •patients with sick sinus syndrome or greater than 1st degree AV block without a pacemaker
- •patients with a pathologic fracture due to metastatic cancer
- •patients with advanced dementia or total functional dependence.
研究组 & 干预措施
1
干预措施: donepezil (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Delirium Using the CAM Over Time
时间窗: Baseline, hospital interviews, weeks 2, 4 and 6
Confusion Assessment Method (CAM)-Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.
次要结局
- Change From Baseline and MDAS Scores Over Time(Baseline, hospital discharge, weeks 2, 4 and 6)
研究者
Edward Marcantonio
Principal Investigator
Beth Israel Deaconess Medical Center
