Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: donepezil Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| 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 |
- rates of side effects and drug withdrawals [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- new delirium symptoms [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: donepezil
5 mg each day for 30 days
Other Name: Aricept
|
| Placebo Comparator: 2 |
Drug: Placebo
Encapsulated cornstarch One capsule daily for 30 days
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Edward R Marcantonio, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided by Beth Israel Deaconess Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Edward R. Marcantonio, MD, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00586196 History of Changes |
| Other Study ID Numbers: | 2006p-000193, R21AG027549 |
| Study First Received: | December 21, 2007 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Deaconess Medical Center:
|
Delirium Postoperative confusion Hip fracture Long bone fracture |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Cholinesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013