Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586196
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Edward Marcantonio, 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.

Condition or disease Intervention/treatment Phase
Delirium Drug: donepezil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period
Study Start Date : January 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change From Baseline and MDAS Scores Over Time [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586196

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute on Aging (NIA)
Principal Investigator: Edward R Marcantonio, MD Beth Israel Deaconess Medical Center

Publications of Results:
Responsible Party: Edward Marcantonio, Principal Investigator, Beth Israel Deaconess Medical Center Identifier: NCT00586196     History of Changes
Other Study ID Numbers: 2006p-000193
R21AG027549 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2008    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014

Keywords provided by Edward Marcantonio, Beth Israel Deaconess Medical Center:
Postoperative confusion
Hip fracture
Long bone fracture

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents