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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:
Collaborator:
University of Louisville
Information provided by:
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00636077
First received: February 20, 2008
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gambro Renal Products, Inc.:

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636077

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

Publications:
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: Richard A. Ward, Ph.D./Professor of Medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT00636077     History of Changes
Other Study ID Numbers: Gambro 1461
Study First Received: February 20, 2008
Results First Received: March 7, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Gambro Renal Products, Inc.:
Hemodialysis
Dialysis, Renal

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013