Comparison of Dialysis Therapies on Cognitive Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00597103
First received: January 8, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted

January 8, 2008
January 8, 2008
December 2007
December 2011   (final data collection date for primary outcome measure)
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]
  • To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Influence of cognitive function on survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Dialysis Therapies on Cognitive Function
Comparison of Dialysis Therapies on Cognitive Function

This study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. Our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of ESRD patients and help to emphasize the need for treatments that will allow patients to live "with dialysis" rather than live "for dialysis".

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.

  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Other: Cognitive Function Testing-10 Tests
    Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
  • Other: Sleep Assessment Testing
    Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
  • Other: Periodic Leg Movement Syndrome Assessment
    Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
  • 1
    Prevalent patients who have been receiving more frequent dialysis.
    Interventions:
    • Other: Cognitive Function Testing-10 Tests
    • Other: Sleep Assessment Testing
    • Other: Periodic Leg Movement Syndrome Assessment
  • 2
    Incident patients new to more frequent dialysis
    Interventions:
    • Other: Cognitive Function Testing-10 Tests
    • Other: Sleep Assessment Testing
    • Other: Periodic Leg Movement Syndrome Assessment
  • 3
    Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.
    Interventions:
    • Other: Cognitive Function Testing-10 Tests
    • Other: Sleep Assessment Testing
    • Other: Periodic Leg Movement Syndrome Assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of ESRD
  • Age 18 years or greater
  • Ability to understand and a willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPPA) authorization statement.
  • Expected survival of at least one year.

Exclusion Criteria:

  • Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.
Both
18 Years and older
No
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Contact: Sheila Doss, RN, CNN, CCRA 650-404-3621 dosss@satellitehealth.com
United States
 
NCT00597103
SR016CF
No
Brigitte Schiller-Moran MD, Satellite Healthcare, Inc.
Satellite Healthcare
Not Provided
Principal Investigator: Brigitte Schiller-Moran, MD Satellite Healthcare, Inc.
Satellite Healthcare
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP