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Sponsors and Collaborators: |
Gambro Renal Products, Inc. University of Louisville |
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Information provided by: | Gambro Renal Products, Inc. |
ClinicalTrials.gov Identifier: | NCT00636077 |
The purposes of this study are to determine if the performance of a dialyzer depends on how tightly the hollow fiber membranes are packed in the housing of the dialyzer (the membrane packing density) and if that dependence is a function of the dialysate flow rate. The study will examine how efficiently three different sized molecules pass through a dialyzer membrane at different dialysate flow rates in dialyzers with different membrane packing densities. Transfer of urea, phosphorus and beta-2-microglobulin from blood to dialysate will be measured during clinical hemodialysis using four different dialyzers, each used at three different dialysate flow rates. The data derived from these measurements may provide insight into the importance of membrane packing density as a design parameter for hemodialyzers and if changing the membrane packing density might provide equivalent performance at a lower dialysate flow rate.
Condition | Intervention |
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Chronic Kidney Disease Chronic Renal Disease |
Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment |
Official Title: | Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities |
Enrollment: | 12 |
Study Start Date: | February 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HD-C4 Big
3 consecutive treatments with the HD-C4 Big dialyzer.
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Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR
Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
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HD-C4 Small
3 consecutive treatments with the HD-C4 Small dialyzer.
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Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR
Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
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F160NR
3 consecutive treatments with the F160NR dialyzer.
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Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR
Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
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F200NR
3 consecutive treatments with the F200NR dialyzer.
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Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR
Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each dialyzer clearances of urea, phosphorus and β2-microglobulin will be determined at a blood flow rate of 400 mL/min and dialysate flow rates of 350 mL/min, 500 mL/min and 800 mL/min.
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
University of Louisville, Kidney Disease Program | |
Louisville, Kentucky, United States, 40202-1718 |
Principal Investigator: | Richard Ward, Ph.D. | University of Louisville |
Responsible Party: | University of Louisville ( Richard A. Ward, Ph.D./Professor of Medicine ) |
Study ID Numbers: | Gambro 1461 |
Study First Received: | February 20, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00636077 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hemodialysis Dialysis, Renal |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |