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Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636077
First Posted: March 14, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Louisville
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
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
Chronic Kidney Disease Chronic Renal Disease Device: Polyflux HD-C4 Big Device: HD-C4 Small Device: Optiflux 160NR Device: Optiflux 200NR

Study Type: Interventional
Study Design: 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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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) ]

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
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:
  • Gambro Polyflux HD-C4 Big dialyzer
  • Gambro Revaclear MAX
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:
  • Gambro Polyflux HD-C4 Small dialyzer
  • Gambro Revaclear dialyzer
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Kentucky
University of Louisville, Kidney Disease Program
Louisville, Kentucky, United States, 40202-1718
Sponsors and Collaborators
Baxter Healthcare Corporation
University of Louisville
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Richard Ward, Ph.D. University of Louisville
  More Information

Publications:
Ward RA, Ouseph R: Comparative evaluation of small and large molecule removal during hemodialysis with Polyflux-S and Fresenius polysulfone membranes. Report to Gambro Renal Products, February 6, 2003.
Ward RA, Ouseph R: A comparison of urea, phosphorus and b2-microglobulin removal during hemodialysis with dialyzers containing Polyflux H and Fresenius Optiflux membranes. Report to Gambro Renal Products, August 29, 2005.
Ward RA, Ouseph R: Modification of membrane characteristics allows a reduction in dialyzer membrane area without loss of performance. J Am Soc Nephrol 18:453A, 2007.
Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00636077     History of Changes
Other Study ID Numbers: Gambro 1461
First Submitted: February 20, 2008
First Posted: March 14, 2008
Results First Submitted: March 7, 2011
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