N/A
N=12
Comparative Effects Of Dialysate Flow Rate And Membrane Packing On The Performance Of Dialyzers Used For Hemodialysis
Chronic Kidney Disease · Chronic Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00636077 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. — 844; 763; 770; 798 KoA for urea (mL/min)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polyflux HD-C4 Big (Device); HD-C4 Small (Device); Optiflux 160NR (Device); Optiflux 200NR (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Vantive Health LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities. |
844; 763; 770; 798; 898; 748 | — |
| PRIMARY Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities. |
279; 270; 271; 274; 315; 295 | — |
| PRIMARY Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities. |
434; 334; 434; 504; 435; 422 | — |
| PRIMARY Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities. |
255; 252; 247; 249; 269; 261 | — |
| PRIMARY Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities. |
65; 61; 27; 27; 62; 57 | — |
| PRIMARY Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities. |
106; 119; 87; 72; 129; 118 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00636077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.