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Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients
This study is currently recruiting participants.
Verified by University of Chicago, August 2008
Sponsored by: University of Chicago
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00739843
  Purpose

The purpose of this study is to estimate how quickly cognitive status and functional status in older patients on hemodialysis declines.


Condition
Dementia
Cognition
End-Stage Renal Disease

MedlinePlus related topics: Dementia Dialysis Kidney Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Cognitive and Functional Status and Dialysis Outcomes in Older Hemodialysis Patients

Further study details as provided by University of Chicago:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: November 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Dialysis outcome measures, which predict morbidity and mortality of younger patients on renal replacement therapy, such as dialysis clearance, do not correlate with survival of the elderly patients on hemodialysis. Survival of older patients on hemodialysis is significantly worse when compared to that of the younger patients. Conditions commonly affecting older adults, such as functional decline, cognitive impairment, depression and declining quality of life have not been well studied in hemodialysis population. There may be an important relationship between these measurements and outcomes in older dialysis patients. Institution of appropriate age-specific interventions could result in improved health status and mortality of older patients on hemodialysis. Our broad objective is to better understand global functioning of the elderly dialysis patients and its possible impact on dialysis outcomes in attempt to improve health care of the older patients receiving hemodialysis.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program at the time of the study will be invited to participate.

Criteria

Inclusion Criteria:

  • Prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the University of Chicago outpatient dialysis program.

Exclusion Criteria:

  • Patients 59 and younger, and patients with the following medical conditions: malignancies currently requiring chemotherapy or radiation therapy, severe heart failure (NYHA class IV), known HIV infection, or currently active hepatic encephalopathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739843

Contacts
Contact: Tiffany Perry, MA 7738345830 tperry@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Chronic Hemodialysis Centers Recruiting
Chicago, Illinois, United States, 60617
Contact: Tiffany Perry, MA     773-834-5830     tperry@medicine.bsd.uchicago.edu    
Principal Investigator: Nicole Stankus, MD, MSc            
Sub-Investigator: Jennifer Ennis, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Nicole Stankus, MD, MSc University of Chicago
  More Information

Responsible Party: The University of Chicago ( Nicole Stankus MD, MSc, Assistant Professor of Medicine )
Study ID Numbers: 15813B
Study First Received: August 20, 2008
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00739843  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Dementia,
Cognitive Disorders,
Hemodialysis

Study placed in the following topic categories:
Renal Insufficiency
Kidney Failure, Chronic
Central Nervous System Diseases
Brain Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Mental Disorders
Kidney Diseases
Dementia
Kidney Failure
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009