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

Primary Purpose

Chronic Kidney Disease, Chronic Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polyflux HD-C4 Big
HD-C4 Small
Optiflux 160NR
Optiflux 200NR
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis, Dialysis, Renal

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville, Kidney Disease Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

HD-C4 Big

HD-C4 Small

F160NR

F200NR

Arm Description

3 consecutive treatments with the HD-C4 Big dialyzer.

3 consecutive treatments with the HD-C4 Small dialyzer.

3 consecutive treatments with the F160NR dialyzer.

3 consecutive treatments with the F200NR dialyzer.

Outcomes

Primary Outcome Measures

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.
Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.
Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.
Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.
Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2008
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Gambro Renal Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00636077
Brief Title
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
Official Title
Effect Of Dialysate Flow Rate On Mass Transfer Coefficient - Area (KoA) In Dialyzers With Different Membrane Packing Densities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Gambro Renal Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Renal Disease
Keywords
Hemodialysis, Dialysis, Renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD-C4 Big
Arm Type
Other
Arm Description
3 consecutive treatments with the HD-C4 Big dialyzer.
Arm Title
HD-C4 Small
Arm Type
Other
Arm Description
3 consecutive treatments with the HD-C4 Small dialyzer.
Arm Title
F160NR
Arm Type
Other
Arm Description
3 consecutive treatments with the F160NR dialyzer.
Arm Title
F200NR
Arm Type
Other
Arm Description
3 consecutive treatments with the F200NR dialyzer.
Intervention Type
Device
Intervention Name(s)
Polyflux HD-C4 Big
Other Intervention Name(s)
Gambro Polyflux HD-C4 Big dialyzer, Gambro Revaclear MAX
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HD-C4 Small
Other Intervention Name(s)
Gambro Polyflux HD-C4 Small dialyzer, Gambro Revaclear dialyzer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Optiflux 160NR
Other Intervention Name(s)
Fresenius Optiflux 160NR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Optiflux 200NR
Other Intervention Name(s)
Fresenius Optiflux 200NR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.
Description
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.
Time Frame
During the third treatment with each dialyzer (one time during each trial period week)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Ward, Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville, Kidney Disease Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1718
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9186896
Citation
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.
Results Reference
background
PubMed Identifier
11157372
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. doi: 10.1053/ajkd.2001.21296.
Results Reference
background
PubMed Identifier
5960730
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. No abstract available.
Results Reference
background
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12558312
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. doi: 10.1097/00002480-200301000-00013.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Chen PS, Toribara TY, Warner H. Microdetermination of phosphorus. Anal Chem 1956; 28: 1756-1758
Results Reference
background
PubMed Identifier
20543211
Citation
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.
Results Reference
result

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

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