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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration

Conditions
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Inflammation, End Stage Renal Disease

Intervention / Treatment
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* Device: VIE A Hemodialyzer
* Device: Rexsys 27H hemodialyzer
* Device: Leoceed 21HX hemodialyzer
* Device: Polypure 22S+ hemodialyzer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective randomized cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemodialysis<br>patients treated by conventionnal hemodialysis | Device: VIE A Hemodialyzer<br>* polysulfon membrane coated with vitamin E<br>Device: Rexsys 27H hemodialyzer<br>* polyethersulfon membrane with large surface area : 2,7m²<br>Device: Leoceed 21HX hemodialyzer<br>* polyslfon membrane with gamma sterilization<br>Device: Polypure 22S+ hemodialyzer<br>* polysulfon membrane with steam sterilization<br>|
| Experimental: Hemodiafiltration post dilution<br>patients treated by HDF post-dilution | Device: VIE A Hemodialyzer<br>* polysulfon membrane coated with vitamin E<br>Device: Rexsys 27H hemodialyzer<br>* polyethersulfon membrane with large surface area : 2,7m²<br>Device: Leoceed 21HX hemodialyzer<br>* polyslfon membrane with gamma sterilization<br>Device: Polypure 22S+ hemodialyzer<br>* polysulfon membrane with steam sterilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | one week per dialyzer per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extraction of uremic toxins | Urea Creatinin inorganic phosphates | one week per dialyzer per patient | 
| Biocompatibility assessment | Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend) TNF-α and IL-6 (T0 et Tend) | one week per dialyzer per patient | 
| Monitoring of Nutrition status | Quantification of the albumin loss in the used dialysate (1 center) during the middle session of the week for each dialyzer tested per patient, i.e 4 times/patient. 2 analysis modalities will be used:  pull and push  syringe Plastipak BD 50mL or collection of the whole dialysate in a 200 L tank Dosage Albumin et pre-albumin before dialysis session | one week per dialyzer per patient | 
| Handling of the devices | - Evaluation of the priming and recovery for each dialysis session | one week per dialyzer per patient | 
| Dialysis adequacy evaluation | Calculation of KT/V | one week per dialyzer per patient | 
| Session tolerance | All secondary troubles will be noted: cramps, nauseas, hypotension… | one week per dialyzer per patient | 
| Parameters inflammation | CRP (mg/l) | one week per dialyzer per patient | 
| Parameters inflammation | - Calcul of PINI = [CRP(mg/l) x Orosomucoïd (mg/l)] / [Albumin(g/l) x Pre-albumin(mg/l)] | one week per dialyzer per patient |