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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636077
• Other study ID #: Gambro 1461
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: June 6, 2011
• Start date: February 2008
• Est. completion date: April 2008

Study information

• Verified date: June 2011
• Source: Gambro Renal Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Polyflux HD-C4 Big
Three consecutive treatments with the HD-C4 Big. During the third treatment, dialyzer clearances of urea, phosphorus and ß2-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
Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and ß2-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.
• Optiflux 160NR
Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and ß2-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.
• Optiflux 200NR
Three consecutive treatments with the HD-C4 Small. During the third treatment dialyzer clearances of urea, phosphorus and ß2-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.

Locations

Country	Name	City	State
United States	University of Louisville, Kidney Disease Program	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Gambro Renal Products, Inc.	University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 201 — View Citation

Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758

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. — View Citation

Leypoldt JK, Cheung AK, Carroll CE, Stannard DC, Pereira BJ, Agodoa LY, Port FK. Effect of dialysis membranes and middle molecule removal on chronic hemodialysis patient survival. Am J Kidney Dis. 1999 Feb;33(2):349-55. — View Citation

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. — View Citation

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

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. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No