Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period|
- Percentage of Participants With Delirium Using the CAM Over Time [ Time Frame: Baseline, hospital interviews, weeks 2, 4 and 6 ] [ Designated as safety issue: Yes ]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.
- Change From Baseline and MDAS Scores Over Time [ Time Frame: Baseline, hospital discharge, weeks 2, 4 and 6 ] [ Designated as safety issue: No ]Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.
|Study Start Date:||January 2007|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
5 mg each day for 30 days
Other Name: Aricept
|Placebo Comparator: 2||
Encapsulated cornstarch One capsule daily for 30 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586196
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Edward R Marcantonio, MD||Beth Israel Deaconess Medical Center|