Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

NCT ID: NCT00012441

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Kidney Failure, Chronic

Keywords

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Renal Dialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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hemodialysis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Brent W. Miller, M.D.

Role: primary

Other Identifiers

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NCRR-M01RR00036-0781

Identifier Type: -

Identifier Source: org_study_id