Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

Hemotech32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease Inflammation

Interventions

VIE A HemodialyzerDEVICE

polysulfon membrane coated with vitamin E

Rexsys 27H hemodialyzerDEVICE

polyethersulfon membrane with large surface area : 2,7m²

Leoceed 21HX hemodialyzerDEVICE

polyslfon membrane with gamma sterilization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test * Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum) * Patient treated before with high permeability membrane * Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min * Patient treated with a high surface area dialyzer ≥ 1,8 m² * Patient covered by the social French health organism * Patient informed of the study goals and having signed the informed consent Exclusion Criteria: * Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min * Patient with a fast progressive chronic disease * Patient with an uncontrolled anemia * Patient refusing to sign the informed consent * Pregnant or nursing patient * Pediatric patient * Patient under tutorship

Locations (1)

AIDER-Lapeyronie

Montpellier, France

Outcomes

Primary Outcomes

Evaluation of middle molecules extraction

Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)