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

Vantive Health LLC

Status: Completed

Conditions: Chronic Kidney Disease; Chronic Renal Disease

Treatments: Device: Optiflux 200NR; Device: Optiflux 160NR; Device: HD-C4 Small; Device: Polyflux HD-C4 Big

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00636077

Gambro 1461

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

HD-C4 Big

Other group

Description:

3 consecutive treatments with the HD-C4 Big dialyzer.

Treatment:

Device: Polyflux HD-C4 Big

HD-C4 Small

Other group

Description:

3 consecutive treatments with the HD-C4 Small dialyzer.

Treatment:

Device: HD-C4 Small

F160NR

Other group

Description:

3 consecutive treatments with the F160NR dialyzer.

Treatment:

Device: Optiflux 160NR

F200NR

Other group

Description:

3 consecutive treatments with the F200NR dialyzer.

Treatment:

Device: Optiflux 200NR