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

Purpose

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.

Condition	Intervention
Chronic Kidney Disease Chronic Renal Disease	Device: Polyflux HD-C4 Big Device: HD-C4 Small Device: Optiflux 160NR Device: Optiflux 200NR


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:

Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]
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.
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]
Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]
Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]
Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities. [ Time Frame: During the third treatment with each dialyzer (one time during each trial period week) ] [ Designated as safety issue: No ]


Enrollment:	12
Study Start Date:	February 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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
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 Name: Fresenius Optiflux 160NR
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 Name: Fresenius Optiflux 200NR

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636077

Locations


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

Sponsors and Collaborators

Gambro Renal Products, Inc.

University of Louisville

Investigators


Principal Investigator:	Richard Ward, Ph.D.	University of Louisville

More Information

Publications:

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.

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.

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.

Michaels AS. Operating parameters and performance criteria for hemodialyzers and other membrane-separation devices. Trans Am Soc Artif Intern Organs. 1966;12:387-92.

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.

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


Responsible Party:	Richard A. Ward, Ph.D./Professor of Medicine, University of Louisville
ClinicalTrials.gov Identifier:	NCT00636077 History of Changes
Other Study ID Numbers:	Gambro 1461
Study First Received:	February 20, 2008
Results First Received:	March 7, 2011
Last Updated:	June 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Gambro Renal Products, Inc.:


Hemodialysis Dialysis, Renal

Additional relevant MeSH terms:


Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases	Renal Insufficiency Dialysis Solutions Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 30, 2016