Clinical trial NCT00586196: Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Official title: Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delirium
Keywords: Delirium
Postoperative confusion
Hip fracture
Long bone fracture
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-01-04
Enrollment: 16
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Delirium Using the CAM Over Time
timeFrame: Baseline, hospital interviews, weeks 2, 4 and 6
Secondary outcomes:
measure: Change From Baseline and MDAS Scores Over Time
timeFrame: Baseline, hospital discharge, weeks 2, 4 and 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Edward R Marcantonio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(Suppl 2):S282-8. doi: 10.1111/j.1532-5415.2011.03691.x.