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Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

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ClinicalTrials.gov Identifier: NCT00012441
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : March 8, 2001
Last Update Posted : June 24, 2005
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Kidney Failure, Chronic Procedure: hemodialysis

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012441

United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63108
Contact: Brent W. Miller, M.D.    314-286-0801      
Principal Investigator: Brent W. Miller, M.D.         
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information

ClinicalTrials.gov Identifier: NCT00012441     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0781
First Posted: March 8, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
Renal Dialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic