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
Recruitment status was Recruiting
Sponsor:
Satellite Healthcare
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 8, 2008 | ||||||||
| Last Updated Date | January 8, 2008 | ||||||||
| Start Date ICMJE | December 2007 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Dialysis Therapies on Cognitive Function | ||||||||
| Official Title ICMJE | Comparison of Dialysis Therapies on Cognitive Function | ||||||||
| Brief Summary | 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". |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00597103 | ||||||||
| Other Study ID Numbers ICMJE | SR016CF | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Brigitte Schiller-Moran MD, Satellite Healthcare, Inc. | ||||||||
| Study Sponsor ICMJE | Satellite Healthcare | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Satellite Healthcare | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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