Functional and Cognitive Impairment in Advanced Kidney Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00905619
First received: May 18, 2009
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

An increasing number of veterans are anticipated to develop chronic kidney disease (CKD) and require hemodialysis (HD) treatments as the veteran population ages. In 2003, approximately 290,000 US citizens were receiving HD and an estimated 19 million were affected by CKD. The annual growth rate is predicted to be 7% per year with 500,000 Americans receiving HD treatment by 2010. In 2005, approximately 2500 veterans were receiving HD with growth expected to parallel that seen in the general population. Whereas Alzheimer's disease is the leading cause of dementia in the general population, growing evidence suggests that patients with advanced CKD experience cognitive deficits related to accelerated cerebrovascular disease. Patients with advanced CKD have been shown to have a high prevalence of sub-clinical cerebrovascular damage on imaging studies and a heavy burden of vascular risk factors such as diabetes, elevated cholesterol, and hypertension. Many of the cognitive deficits related to cerebrovascular disease may go unrecognized by routine measures of cognition. HD patients have increased number of hospitalizations, and several compliance issues ranging from congestive heart failure to dangerous electrolyte imbalances. Impaired cognition in this population is likely to have a significant impact on self-care and compliance with complex medical regimens. Currently, the severity and scope of cognitive impairment related to vascular disease is not well known in patients with advanced kidney disease. Additionally, the relationship between cognitive impairment and measures of self-care independence are not well known. Loss of independence and function secondary to impaired cognitive function is likely to be a significant problem for patients with advanced kidney disease. Early identification of functional impairment, particularly instrumental activities of daily living (IADL), will allow for rehabilitation intervention. Maintaining or improving functional independence through intensive rehabilitation could translate into better compliance and lower hospitalization rate among HD patients. Information obtained from this study is likely to heighten awareness of cognitive impairment and the functional consequences in veterans with advanced kidney disease. Primary objectives are to determine:

  1. The range of cognitive deficits with emphasis on domains affected by vascular disease in patients with advanced CKD and those receiving hemodialysis.
  2. The associations between severity of cognitive impairment and severity of kidney disease.
  3. The prevalence of impaired IADLs and the level of health-related quality of life (HRQOL) in patients with advanced CKD and those requiring hemodialysis.
  4. The relationship or association of cognitive impairment with IADL and HRQOL.

Secondary objective is to determine:

1. The relationships among cerebral and carotid blood flow, carotid artery stiffness, and renal specific metabolic abnormalities with cognitive impairment.


Condition
Kidney Insufficiency, Chronic

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Functional and Cognitive Impairment in Advanced Kidney Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Neuropsychological Assessments [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum obtained and kept until end of study.


Estimated Enrollment: 190
Study Start Date: December 2006
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Hemodialysis Patients
Group 2
Chronic Kidney Disease Patients NOT on Dialysis
Group 3
Control Subjects WITHOUT Kidney Disease

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Veterans at the Bronx VA Renal Clinic, Hemodialysis Unit, and Primary Care Clinic

Criteria

Inclusion Criteria:

PreHD Subjects:

  • Male or female with an age of 18 years or older (no upper limit);
  • Patients with stage III-IV CKD attending the renal primary care clinic or renal consult clinic;
  • Fluent in English;
  • Outpatient or stable nursing home patient

HD Subjects:

  • Receiving HD for at least two weeks;
  • Male or female with an age of 18 years or older (no upper limit);
  • Fluent in English;
  • Outpatient or stable nursing home patient

Control Subjects:

  • Glomerular filtration rate of 60 cc/minute or greater;
  • Male or female with an age of 18y or older (no upper limit);
  • Fluent in English
  • Outpatient

Exclusion Criteria:

PreHD Subjects:

  • Acute illness;
  • Clinical history of stroke, dementia, or Parkinson's disease;
  • Hb <10;
  • Liver function tests 2x upper limit of normal;
  • Hemodialysis

HD Subjects:

  • Acute illness;
  • Clinical history of stroke, dementia, or Parkinson's disease;
  • Hb <10;
  • Liver function tests 2x upper limit of normal;
  • URR <65% (measure of dialysis adequacy: will use 3-month average from chart)

Control Subjects:

  • Acute illness;
  • Clinical history of stroke, dementia, or Parkinson's disease;
  • Hb <10;
  • Liver function tests 2x upper limit of normal;
  • Stage 3-4 CKD;
  • Hemodialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905619

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: James B. Post, MD VA Medical Center, Bronx
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00905619     History of Changes
Other Study ID Numbers: B5050W-1
Study First Received: May 18, 2009
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kidney Diseases
Cognition Disorders
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014