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

Study Overview
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Brief Summary
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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.

Official Title
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Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities

Conditions
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Chronic Kidney Disease, Chronic Renal Disease

Intervention / Treatment
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* Device: Polyflux HD-C4 Big
* Device: HD-C4 Small
* Device: Optiflux 160NR
* Device: Optiflux 200NR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HD-C4 Big<br>3 consecutive treatments with the HD-C4 Big dialyzer. | Device: Polyflux HD-C4 Big<br>* 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.<br>* Other names: Gambro Revaclear MAX;|
| Other: HD-C4 Small<br>3 consecutive treatments with the HD-C4 Small dialyzer. | Device: HD-C4 Small<br>* 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.<br>* Other names: Gambro Revaclear dialyzer;|
| Other: F160NR<br>3 consecutive treatments with the F160NR dialyzer. | Device: Optiflux 160NR<br>* 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.<br>* Other names: Fresenius Optiflux 160NR;|
| Other: F200NR<br>3 consecutive treatments with the F200NR dialyzer. | Device: Optiflux 200NR<br>* 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.<br>* Other names: Fresenius Optiflux 200NR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. | 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. | During the third treatment with each dialyzer (one time during each trial period week) | 
| 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 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 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Dialysis, Renal