Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP)
Status and phase
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Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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