End Stage Renal Disease, Inflammation
Conditions
Brief summary
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
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
Interventions
DEVICEVIE A Hemodialyzer
polysulfon membrane coated with vitamin E
DEVICERexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
DEVICELeoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
DEVICEPolypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization
Sponsors
Hemotech
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of middle molecules extraction | one week per dialyzer per patient | Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biocompatibility assessment | one week per dialyzer per patient | * Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend) * TNF-α and IL-6 (T0 et Tend) |
| Monitoring of Nutrition status | one week per dialyzer per patient | 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 |
| Handling of the devices | one week per dialyzer per patient | \- Evaluation of the priming and recovery for each dialysis session |
| Extraction of uremic toxins | one week per dialyzer per patient | * Urea * Creatinin * inorganic phosphates |
| Session tolerance | one week per dialyzer per patient | All secondary troubles will be noted: cramps, nauseas, hypotension… |
| Parameters inflammation | one week per dialyzer per patient | CRP (mg/l) |
| Dialysis adequacy evaluation | one week per dialyzer per patient | Calculation of KT/V |
Countries
France
Outcome results
None listed