End Stage Renal Disease
Conditions
Brief summary
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
Detailed description
Cognitive impairment is very common in patients with End Stage Renal Disease (ESRD). It exact mechanisms are not clear, but patients with ESRD have more cerebral white matter changes. Several studies have shown that cognitive function improves post-transplant, indicating that there may be some reversibility in the process. This study will examine the correlation between cognitive impairment and structural brain changes before and after renal transplantation. We will also study the correlation of cognitive function with serum inflammatory markers before and after transplant. These results will be compared to aged matched healthy controls without kidney disease.
Interventions
PROCEDUREKidney Transplant
Kidney Transplant Surgery
OTHERNo kidney transplant
The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.
Sponsors
University of Kansas Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pre-transplant ESRD patients who are listed for renal transplantation * Able to sign pre-transplant consent on their own will * Have english as their native language
Exclusion criteria
* Current use of antipsychotics or anti-epileptics * Inability to read or write which will limit their ability to perform the cognitive tests * Claustrophobia or inability to get MRI for other reasons * Unable to sign consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function | Change from Baseline to 3 Months and 12 Months after Renal Transplant | Cognition will be assessed using relevant neuropsychological tests used by National Alzheimers Coordination center (NACC) uniform data set (UDS). Primary outcome will be logical memory. Score range 0-25. Higher scores indicate better cognitive function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory markers | Change from Baseline to 3 months and 12 months post transplant | — |
| Change in verbal declarative/episodic memory | Change from Baseline to 3 Months and 12 Months after Renal Transplant | WMS-R Logical Memory I- Immediate is a test where a brief story is read to subject, who is then asked to retell it from memory immediately; primary measure of performance is number of story units recalled. Scores are from 0-25 with higher scores indicating better cognition. |
| Change in delayed verbal declarative/episodic memory | Change from Baseline to 3 Months and 12 Months after Renal Transplant | WMS-R Logical Memory II- Delayed measures delayed recall of story read to the participant at the beginning of testing session (WMS-R Logical Memory I- Immediate). Scores range from 0-25 with higher scores indicating better cognition. |
| Change in brain MRI | Change from Baseline to 3 Months and 12 months after Renal Transplant | Brain MRI will be performed before and after transplant |
| Change in general dementia screening score | Change from Baseline to 3 Months and 12 Months after Renal Transplant | Mini-Mental State Examination Screening scale evaluates orientation to place, orientation to time, registration, attention and concentration, recall, language, and visual construction. Scores range from 0-30 with higher scores indicate better cognition. |
| Change in working memory or attention | Change from Baseline to 3 Months and 12 Months after Renal Transplant | Digit Span forward and backward are tests where a subject is read sequences of increasing length and asked to repeat them. Digit span length is the length of the highest digit sequence the subject is able to repeat correctly. Scores range from 0-12 with higher scores indicate better cognition. |
| Change in psychomotor speed and visuospatial function | Change from Baseline to 3 Months and 12 Months after Renal Transplant | WAIS-R Digit Symbol Substitution test is where a subject is given a key consisting of numbers 1-9, each paired with a unique, easy-to-draw symbol; subject fills in corresponding symbol for each number in a limited time. Scores are from 0-133 with higher scores indicating better cognition. |
Countries
United States
Outcome results
None listed