Inflammation Clinical Trial
Official title:
Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per
group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and
patient profile.
To evaluate the different hemodialyzers and judge their extraction performances in HD and
post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory
status.
Medical devices studied :
- Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in
Germany
- Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in
Germany
- VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by
Asahi Kasei Medical in Japan
- Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in
Italia
These hemodialyzers are EC marked and are used in their own indications.
Schema
Details of the cross-over plan :
8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated
with the dialyzer "test" for the two first sessions of the week. During the last dialysis
session of each week, only their usual dialyzer will be used as wash-out. A randomization
will define the order of use of the dialyzers in the 4 centers. This order will be identical
in a center.
Number of patients :
32 (8 patients per center (4 centers))
Duration :
One week per dialyzer
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