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

Sponsors and Collaborators:	Gambro Renal Products, Inc. University of Louisville
Information provided by:	Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:	NCT00636077

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: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Phosphorus

U.S. FDA Resources

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

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

Primary Outcome Measures:

A comparison of the effect of increased dialysate flow rate on solute clearance between 4 dialyzers with different membrane packing densities. [ Time Frame: Third treatment with each dialyzer. ] [ 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: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each 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.
HD-C4 Small 3 consecutive treatments with the HD-C4 Small dialyzer.	Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each 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.
F160NR 3 consecutive treatments with the F160NR dialyzer.	Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each 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.
F200NR 3 consecutive treatments with the F200NR dialyzer.	Device: Dialyzers: Polyflux HD-C4 Big/Small, Optiflux 160NR/200NR Each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments). During the third treatment with each 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.

Eligibility

Ages Eligible for Study:	19 Years and older
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

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:

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. No abstract available.

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:	University of Louisville ( Richard A. Ward, Ph.D./Professor of Medicine )
Study ID Numbers:	Gambro 1461
Study First Received:	February 20, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00636077
Health Authority:	United States: Institutional Review Board

Keywords provided by Gambro Renal Products, Inc.:

Hemodialysis
Dialysis, Renal

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009