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

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.

Conditions

• Chronic Kidney Disease
• Chronic Renal Disease

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

• University of Louisville

  collaborator OTHER

• Gambro Renal Products, Inc.

  collaborator INDUSTRY

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Vantive Health LLC

  lead INDUSTRY

Principal Investigators

• Richard Ward, Ph.D. · University of Louisville

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2008-04-30

Completion

2008-04-30

Countries

• United States

Study Locations