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

Not Applicable
Completed
Conditions
Chronic Renal Disease
Chronic Kidney Disease
Interventions
Device: Optiflux 160NR
Device: HD-C4 Small
Device: Polyflux HD-C4 Big
Device: Optiflux 200NR
Registration Number
NCT00636077
Lead Sponsor
Vantive Health LLC
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
F160NROptiflux 160NR3 consecutive treatments with the F160NR dialyzer.
HD-C4 SmallHD-C4 Small3 consecutive treatments with the HD-C4 Small dialyzer.
HD-C4 BigPolyflux HD-C4 Big3 consecutive treatments with the HD-C4 Big dialyzer.
F200NROptiflux 200NR3 consecutive treatments with the F200NR dialyzer.
Primary Outcome Measures
NameTimeMethod
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.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.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.During the third treatment with each dialyzer (one time during each trial period week)
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.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.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.During the third treatment with each dialyzer (one time during each trial period week)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Louisville, Kidney Disease Program

🇺🇸

Louisville, Kentucky, United States

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