Delirium Clinical Trial
— SHARPOfficial title:
Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | National Institute on Aging (NIA) |
United States,
Marcantonio ER, Palihnich K, Appleton P, Davis RB. Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture. J Am Geriatr Soc. 2011 Nov;59 Suppl 2:S282-8. doi: 10.1111/j.1532-5415.2011.03691.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Delirium Using the CAM Over Time | 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. | Baseline, hospital interviews, weeks 2, 4 and 6 | Yes |
Secondary | Change From Baseline and MDAS Scores Over Time | 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. | Baseline, hospital discharge, weeks 2, 4 and 6 | No |
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