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Brief Title † | Phase II Randomized Study of Standard Vs High Amount of Hemodialysis Using Low Vs High Flux Dialyzer Membranes for End Stage Renal Disease | ||||
Official Title † | |||||
Brief Summary | OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease. II. Compare the efficacy of high versus low flux dialyzer membranes. |
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Detailed Description | PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation. Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics. Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted. The intervention phase of this study is 5 years. Patients are followed for survival. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Efficacy Study | ||||
Primary Outcome Measure † | |||||
Secondary Outcome Measure † | |||||
Condition † | End Stage Renal Disease | ||||
Intervention † | Procedure: Dialysis | ||||
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Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 900 | ||||
Start Date † | October 1992 | ||||
Completion Date | December 2001 | ||||
Eligibility Criteria † | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00004285 | ||||
Organization ID | 199/11704 | ||||
Secondary IDs †† | URSMD-HEMO-5813 | ||||
Study Sponsor † | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
Collaborators †† | University of Rochester | ||||
Investigators † |
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Information Provided By | Office of Rare Diseases (ORD) | ||||
Verification Date | July 2002 | ||||
First Received Date † | October 18, 1999 | ||||
Last Updated Date | June 23, 2005 |