NCT00012441

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

March 6, 2001

Last Update Submit

June 23, 2005

Conditions

Keywords

Renal Dialysis

Interventions

hemodialysisPROCEDURE

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 6, 2001

First Posted

March 8, 2001

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations