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NCT00012441 Clinical Trial

Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Kidney Failure, Chronic Clinical Trial

Official title:
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00012441
Other study ID # NCRR-M01RR00036-0781
Secondary ID
Status Recruiting
Phase N/A
First received March 6, 2001
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 75 Years
Eligibility Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• hemodialysis

Locations
Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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