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

Phase 2

Completed

• Conditions: Delirium
• Interventions: Drug: donepezil; Drug: Placebo

• Registration Number: NCT00586196
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2013-02-28
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-08-22
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	donepezil	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Delirium Using the CAM Over Time	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 Outcome Measures

Name	Time	Method
Change From Baseline and MDAS Scores Over Time	Baseline, hospital discharge, weeks 2, 4 and 6	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States