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

February 20, 2008
June 6, 2011
February 2008
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
A comparison of the effect of increased dialysate flow rate on solute clearance between 4 dialyzers with different membrane packing densities. [ Time Frame: Third treatment with each dialyzer. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00636077 on ClinicalTrials.gov Archive Site
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Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities

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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Chronic Renal Disease
  • 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
  • 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
  • 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
  • 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
  • HD-C4 Big
    3 consecutive treatments with the HD-C4 Big dialyzer.
    Intervention: Device: Polyflux HD-C4 Big
  • HD-C4 Small
    3 consecutive treatments with the HD-C4 Small dialyzer.
    Intervention: Device: HD-C4 Small
  • F160NR
    3 consecutive treatments with the F160NR dialyzer.
    Intervention: Device: Optiflux 160NR
  • F200NR
    3 consecutive treatments with the F200NR dialyzer.
    Intervention: Device: Optiflux 200NR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636077
Gambro 1461
No
Richard A. Ward, Ph.D./Professor of Medicine, University of Louisville
Gambro Renal Products, Inc.
University of Louisville
Principal Investigator: Richard Ward, Ph.D. University of Louisville
Gambro Renal Products, Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP