NCT00636077

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2008-03-14
• Last updated: 2025-07-14
• Results posted: 2011-07-01

Locations

1 site across 1 country: United States