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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Chronic Renal Disease
• Intervention / Treatment: Device: Polyflux HD-C4 Big; Device: HD-C4 Small; Device: Optiflux 160NR; Device: Optiflux 200NR

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202-1718
      • University of Louisville, Kidney Disease Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation; University of Louisville; Gambro Renal Products, Inc.
• Investigators: Principal Investigator: Richard Ward, Ph.D., University of Louisville

Publications and helpful links

General Publications

• Leypoldt JK, Cheung AK, Agodoa LY, Daugirdas JT, Greene T, Keshaviah PR. Hemodialyzer mass transfer-area coefficients for urea increase at high dialysate flow rates. The Hemodialysis (HEMO) Study. Kidney Int. 1997 Jun;51(6):2013-7. doi: 10.1038/ki.1997.274.
• Ouseph R, Ward RA. Increasing dialysate flow rate increases dialyzer urea mass transfer-area coefficients during clinical use. Am J Kidney Dis. 2001 Feb;37(2):316-20. doi: 10.1053/ajkd.2001.21296.
• Michaels AS. Operating parameters and performance criteria for hemodialyzers and other membrane-separation devices. Trans Am Soc Artif Intern Organs. 1966;12:387-92. No abstract available.
• Ward RA, Ouseph R: Comparative evaluation of small and large molecule removal during hemodialysis with Polyflux-S and Fresenius polysulfone membranes. Report to Gambro Renal Products, February 6, 2003.
• Ward RA, Ouseph R: A comparison of urea, phosphorus and b2-microglobulin removal during hemodialysis with dialyzers containing Polyflux H and Fresenius Optiflux membranes. Report to Gambro Renal Products, August 29, 2005.
• Leypoldt JK, Cheung AK, Chirananthavat T, Gilson JF, Kamerath CD, Deeter RB. Hollow fiber shape alters solute clearances in high flux hemodialyzers. ASAIO J. 2003 Jan-Feb;49(1):81-7. doi: 10.1097/00002480-200301000-00013.
• Ward RA, Ouseph R: Modification of membrane characteristics allows a reduction in dialyzer membrane area without loss of performance. J Am Soc Nephrol 18:453A, 2007.
• Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758
• Bhimani JP, Ouseph R, Ward RA. Effect of increasing dialysate flow rate on diffusive mass transfer of urea, phosphate and beta2-microglobulin during clinical haemodialysis. Nephrol Dial Transplant. 2010 Dec;25(12):3990-5. doi: 10.1093/ndt/gfq326. Epub 2010 Jun 13.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimated): March 14, 2008

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hemodialysis; Dialysis, Renal
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Other Study ID Numbers: Gambro 1461