跳至主要内容
临床试验/NCT00586196
NCT00586196已完成2 期

Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: donepezil (Drug)

2

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Marcantonio

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (1)

Loading locations...

相似试验