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Donepezil in Preventing Delirium in Hospitalized Elderly

Primary Purpose

Postoperative Complications, Delirium

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Donepezil
Sponsored by
Indiana University Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Hospital acquired complications, adverse effects, Cognitive Impairment, Aging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Community-dwelling individuals aged 65 or older Admitted to Methodist Hospital for surgical repair of hip fracture No evidence of delirium at admission to hospital MMSE total score below 24 points after adjustment for education and age Consent to participate in the study Exclusion Criteria: Severely demented as defined by MMSE score below 10 Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months Multiple trauma or pathological fractures Aphasic, legally blind, or deaf Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery Allergy to Donepezil

Sites / Locations

  • Methodist Hospital, Clarian Health Partners

Outcomes

Primary Outcome Measures

Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)

Secondary Outcome Measures

Cognitive status as measured by the Mini Mental Status Exam (MMSE)
behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
length of stay in hospital postoperatively
discharge site
adverse effects
use of psychotropic medications

Full Information

First Posted
September 9, 2005
Last Updated
February 28, 2008
Sponsor
Indiana University Health
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1. Study Identification

Unique Protocol Identification Number
NCT00182884
Brief Title
Donepezil in Preventing Delirium in Hospitalized Elderly
Official Title
Preventing Delirium in Hospitalized Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University Health

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.
Detailed Description
Delirium is confusion or a sudden change in alertness which may happen after hip repair surgery. Up to 65% of elderly undergoing surgical repair of hip fracture experience post-operative delirium. These individuals often stay in the hospital longer, have more complications, and are more likely to die. Early studies suggest that delirium could be prevented by correcting the central cholinergic deficit that is associated with delirium. Donepezil is currently being used to treat memory loss in patients with Alzheimer's disease. This study will recruit 30 adults aged 65 or older who are undergoing hip fracture surgery. Participants will be randomized to receive either Donepezil or a matching placebo within 24 hours prior to surgery and for 4 days after the surgery. All material to be collected will be from interviews, questionnaires, and medical chart review at baseline and daily for the entire hospital stay. The Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS) will be used to evaluate the effect of Donepezil on delirium incidence and severity. Other assessments include cognitive deficit, length of hospitalization, discharge site, adverse effects, and psychotropic medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Delirium
Keywords
Hospital acquired complications, adverse effects, Cognitive Impairment, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Donepezil
Primary Outcome Measure Information:
Title
Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge
Title
delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS)
Secondary Outcome Measure Information:
Title
Cognitive status as measured by the Mini Mental Status Exam (MMSE)
Title
behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE)
Title
length of stay in hospital postoperatively
Title
discharge site
Title
adverse effects
Title
use of psychotropic medications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community-dwelling individuals aged 65 or older Admitted to Methodist Hospital for surgical repair of hip fracture No evidence of delirium at admission to hospital MMSE total score below 24 points after adjustment for education and age Consent to participate in the study Exclusion Criteria: Severely demented as defined by MMSE score below 10 Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months Multiple trauma or pathological fractures Aphasic, legally blind, or deaf Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery Allergy to Donepezil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malaz Boustani, MD, MPH
Organizational Affiliation
Regenstrief Institute, Indiana University Center for Aging Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital, Clarian Health Partners
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2240918
Citation
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
Results Reference
background
PubMed Identifier
1421796
Citation
Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
Results Reference
background
PubMed Identifier
2302881
Citation
Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.
Results Reference
background
PubMed Identifier
7709931
Citation
Barrett-Connor E. The economic and human costs of osteoporotic fracture. Am J Med. 1995 Feb 27;98(2A):3S-8S. doi: 10.1016/s0002-9343(05)80037-3. No abstract available.
Results Reference
background
PubMed Identifier
11333420
Citation
Galanakis P, Bickel H, Gradinger R, Von Gumppenberg S, Forstl H. Acute confusional state in the elderly following hip surgery: incidence, risk factors and complications. Int J Geriatr Psychiatry. 2001 Apr;16(4):349-55. doi: 10.1002/gps.327.
Results Reference
background
PubMed Identifier
2897391
Citation
Gustafson Y, Berggren D, Brannstrom B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. doi: 10.1111/j.1532-5415.1988.tb04023.x.
Results Reference
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Donepezil in Preventing Delirium in Hospitalized Elderly

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