Chronic Kidney Disease
Conditions
Keywords
CKD dialysis, hemodialysis, hemodiafiltration, Elisio dialyzer, efficacy, biocompatibility
Brief summary
The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.
Detailed description
Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.
Interventions
DEVICEElisio-210H
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
PROCEDUREconventional hemodialysis
comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
PROCEDUREon line hemodiafiltration
comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer
Sponsors
Nipro Europe N.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CKD dialysis patients on treatment with three times a week HD for more than three months * with a stable anticoagulation scheme * with haemoglobin level \>10.5 g/dL * with vascular access allowing a stable blood flow of 300 mL/min during treatment
Exclusion criteria
* patient already enrolled in another study * pregnancy * symptoms or signs of acute/chronic inflammatory or infectious diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pre-dialytic serum beta-2 microglobulin level | Month 1 (after one month) |
Secondary
| Measure | Time frame |
|---|---|
| dialysis dose (urea KT/V) | Month 0, 1, 2, 3, 4 |
| instantaneous clearance of low molecular weight solutes (urea and creatinine) | Month 0, 1, 2, 3, 4 |
| inflammatory markers (CRP, fibrinogen, orosomucoide) | month 0, 1, 2, 3, 4 |
| inflammatory marker (interkeukin 6) | month 0, 4 |
| nutritional status (albumin, transthyretin, homocysteine) | Month 0, 1, 2, 3, 4 |
| endothelial progenitor cells | Month 0, 1, 2, 3, 4 |
| reduction rate of low molecular weight solutes (urea and creatinine) | Month 0, 1, 2, 3, 4 |
| kappa and lambda light chains | Month 0, 4 |
| oxidative stress parameters (superoxide anion, AOPPs, AGEs) | Month 0, 4 |
| coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII) | Month 0, 4 |
| apoptosis markers (soluble FAS and FAS ligand) | Month 0, 4 |
| bone markers (bone PAL, Cross Laps, TRAP5b) | Month 0, 4 |
| inflammatory mononuclear cell activation | Month 0, 1, 2, 3, 4 |
Countries
France
Outcome results
None listed