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

Delirium Clinical Trial

— SHARP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586196
• Other study ID #: 2006p-000193
• Secondary ID: R21AG027549
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: August 21, 2014
• Start date: January 2007
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• donepezil
5 mg each day for 30 days
• Placebo
Encapsulated cornstarch One capsule daily for 30 days

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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:S282-8. doi: 10.1111/j.1532-5415.2011.03691.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Delirium Using the CAM Over Time	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.	Baseline, hospital interviews, weeks 2, 4 and 6	Yes
Secondary	Change From Baseline and MDAS Scores Over Time	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.	Baseline, hospital discharge, weeks 2, 4 and 6	No