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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.
Medical devices studied :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis | Experimental | patients treated by conventionnal hemodialysis |
|
| Hemodiafiltration post dilution | Experimental | patients treated by HDF post-dilution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIE A Hemodialyzer | Device | polysulfon membrane coated with vitamin E |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Extraction of uremic toxins |
| one week per dialyzer per patient |
| Biocompatibility assessment |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Paul CRISTOL, Professor | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDER-Lapeyronie | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26656534 | Background | Kokubo K, Kurihara Y, Kobayashi K, Tsukao H, Kobayashi H. Evaluation of the Biocompatibility of Dialysis Membranes. Blood Purif. 2015;40(4):293-7. doi: 10.1159/000441576. Epub 2015 Nov 17. | |
| 26672890 | Background | Maduell F, Moreso F, Mora-Macia J, Pons M, Ramos R, Carreras J, Soler J, Torres F; study group ESHOL. ESHOL study reanalysis: All-cause mortality considered by competing risks and time-dependent covariates for renal transplantation. Nefrologia. 2016;36(2):156-63. doi: 10.1016/j.nefro.2015.10.007. Epub 2015 Dec 8. English, Spanish. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Prospective randomized cross-over study
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| Rexsys 27H hemodialyzer | Device | polyethersulfon membrane with large surface area : 2,7m² |
|
| Leoceed 21HX hemodialyzer | Device | polyslfon membrane with gamma sterilization |
|
| Polypure 22S+ hemodialyzer | Device | polysulfon membrane with steam sterilization |
|
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |