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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 6, 2001 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00012441 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis |
| Official Title ICMJE | Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis |
| Brief Summary | Hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. Several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. Whether this form of treatment can be expanded to the 220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If the pilot study is effective, then participation in a larger, multicenter trial is expected. The endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys, and improvement in physical function as measured by maximal oxygen uptake. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Efficacy Study |
| Condition ICMJE | Kidney Failure, Chronic |
| Intervention ICMJE | Procedure: hemodialysis |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years |
| Gender | Both |
| Ages | 21 Years to 75 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00012441 |
| Responsible Party | |
| Study ID Numbers ICMJE | NCRR-M01RR00036-0781 |
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Center for Research Resources (NCRR) |
| Verification Date | December 2003 |
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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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