Cognitive Impairment in Kidney Disease

NCT00905619 | Completed

• 1 other identifier: B5050W-1
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The range of cognitive deficits with emphasis on domains affected by vascular disease in patients with advanced CKD and those receiving hemodialysis.
2. 2.The associations between severity of cognitive impairment and severity of kidney disease.
3. 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. 4.The relationship or association of cognitive impairment with IADL and HRQOL.

Conditions

Kidney Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Assessments

  battery of neurocognitive tests

  1 year

Study Arms (3)

Control

No kidney disease

PreHD kidney disease

Kidney disease stage 4 or below

Hemodialysis

Kidney disease receiving hemodialysis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (2)

• Post JB, Jegede AB, Morin K, Spungen AM, Langhoff E, Sano M. Cognitive profile of chronic kidney disease and hemodialysis patients without dementia. Nephron Clin Pract. 2010;116(3):c247-55. doi: 10.1159/000317206. Epub 2010 Jul 2.

  PMID: 20606486 RESULT

• Post JB, Morin KG, Handrakis JP, Rivera DR, Yen C, Sano M, Spungen AM. Cognition may be related to arterial pulsatility index in HD patients. Clin Nephrol. 2014 May;81(5):313-9. doi: 10.5414/cn107998.

  PMID: 24780553 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum obtained and kept until end of study.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James B Post, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: December 1, 2006
• Primary Completion: September 28, 2012
• Study Completion: July 20, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)