Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
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ClinicalTrials.gov Identifier: NCT00636077 |
Recruitment Status
:
Completed
First Posted
: March 14, 2008
Results First Posted
: July 1, 2011
Last Update Posted
: May 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Chronic Renal Disease | Device: Polyflux HD-C4 Big Device: HD-C4 Small Device: Optiflux 160NR Device: Optiflux 200NR | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |
Arm | Intervention/treatment |
---|---|
HD-C4 Big
3 consecutive treatments with the HD-C4 Big dialyzer.
|
Device: Polyflux HD-C4 Big
Three consecutive treatments with the HD-C4 Big. During the third treatment, 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.
Other Names:
|
HD-C4 Small
3 consecutive treatments with the HD-C4 Small dialyzer.
|
Device: HD-C4 Small
Three consecutive treatments with the HD-C4 Small. During the third treatment 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.
Other Names:
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F160NR
3 consecutive treatments with the F160NR dialyzer.
|
Device: Optiflux 160NR
Three consecutive treatments with the HD-C4 Small. During the third treatment 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.
Other Name: Fresenius Optiflux 160NR
|
F200NR
3 consecutive treatments with the F200NR dialyzer.
|
Device: Optiflux 200NR
Three consecutive treatments with the HD-C4 Small. During the third treatment 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.
Other Name: Fresenius Optiflux 200NR
|
- Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.
- Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]
- Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]
- Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]
- Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]
- Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ]

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Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stable hemodialysis patients dialyzing through a native fistula or Gore-Tex graft. The access must be capable of delivering a stable blood flow of 400 ml/min.
- Age older than 18 years.
- Fluid removal requirement less than 3 liters per treatment.
Exclusion Criteria:
- Noncompliance with dialysis regimen.
- Hematocrit less than 28%.
- Active infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636077
United States, Kentucky | |
University of Louisville, Kidney Disease Program | |
Louisville, Kentucky, United States, 40202-1718 |
Principal Investigator: | Richard Ward, Ph.D. | University of Louisville |
Publications of Results:
Other Publications:
Responsible Party: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00636077 History of Changes |
Other Study ID Numbers: |
Gambro 1461 |
First Posted: | March 14, 2008 Key Record Dates |
Results First Posted: | July 1, 2011 |
Last Update Posted: | May 10, 2017 |
Last Verified: | April 2017 |
Keywords provided by Baxter Healthcare Corporation:
Hemodialysis Dialysis, Renal |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases |
Renal Insufficiency Dialysis Solutions Pharmaceutical Solutions |