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Functional and Cognitive Impairment in Advanced Kidney Disease
Sponsor study identifier
observational
117
1 country
1
Study Start
December 1, 2006
Actual (reported)Primary Completion
September 28, 2012
Actual (reported)Study Completion
July 20, 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2006
Actual (reported)May 18, 2009
Actual (reported)May 20, 2009
Actual (reported)September 28, 2012
Actual (reported)July 20, 2017
Actual (reported)Neuropsychological Assessments
battery of neurocognitive tests
1 year
No kidney disease
Kidney disease stage 4 or below
Kidney disease receiving hemodialysis
Veterans at the Bronx VA Renal Clinic, Hemodialysis Unit, and Primary Care Clinic
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
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.
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.
Serum obtained and kept until end of study.
James B Post, MD
James J. Peters Veterans Affairs Medical Center
117 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2009
First Posted
May 20, 2009
Study Start
December 1, 2006
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
September 28, 2012
Actual (reported)Study Completion
July 20, 2017
Actual (reported)Last Updated
August 18, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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