Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

June 23, 2005 updated by: National Center for Research Resources (NCRR)
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Brent W. Miller, M.D.
          • Phone Number: 314-286-0801
        • Principal Investigator:
          • Brent W. Miller, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 6, 2001

First Submitted That Met QC Criteria

March 7, 2001

First Posted (Estimate)

March 8, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00036-0781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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