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Clinical Trials/NCT00586196
NCT00586196
Completed
Phase 2

Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Beth Israel Deaconess Medical Center1 site in 1 country16 target enrollmentJanuary 2007
ConditionsDelirium
InterventionsdonepezilPlacebo

Overview

Phase
Phase 2
Intervention
donepezil
Conditions
Delirium
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
16
Locations
1
Primary Endpoint
Percentage of Participants With Delirium Using the CAM Over Time
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Edward Marcantonio

Principal Investigator

Beth Israel Deaconess Medical Center

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.

Arms & Interventions

1

Intervention: donepezil

2

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants With Delirium Using the CAM Over Time

Time Frame: Baseline, hospital interviews, weeks 2, 4 and 6

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.

Secondary Outcomes

  • Change From Baseline and MDAS Scores Over Time(Baseline, hospital discharge, weeks 2, 4 and 6)

Study Sites (1)

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