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Evaluation of the effect of a vitamin E coated high flux polysulfone dialyzer on the inflammatory state of patients' end stage renal disease and its clinical benefits in terms of anemia Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Prospective multicenter controlled and randomized study Number of patients : 120 patients (60 patients per group)
Coordinator : Pr JP.CRISTOL Montpellier hospital university Rational : The hemodialyzed patients are subject to inflammation due to their pathologies and to the technique. The VIE dialyzer polysulfon coated to vitamin E has been shown to have a favourable action on inflammation and anemia. The investigators want to highlight the influence of vitamine E graft using as controlled dialyzer a similar polysulfon from the same manufacturer without vitamin E.
Medical device : ViE High flux dialyzer -> vitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure Controlled medical device : Leoceed H high flux dialyzer : polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure Objectives : To assess the benefits of a vitamin E coated polysulfone membrane on the micro-inflammatory state of chronic dialysis patients Primary end point : Evolution of the well-known inflammatory marker : High sensibility-CRP Secondary end point : Evolution of the following inflammatory markers : IL-6, TNFa, fibrinogen, antibodies anti- LDLox Evolution of Hemoglobin and ERI Evolution of Nutritional parameters : albumin and pre albumin Study design : Prospective multicenter controlled and randomized protocol study Duration : 12 months Number of patients : 120 patients : 60 patients per group 120 patients : 60 patients per group Adult ESRD patient, whatever the origin, treated by HD, thrice a week for about 4 hours and hemo dynamically well balanced Inclusion criteria : Dialyzed patient on synthetic high flux dialyzer for 3 months Patient with a vascular access allowing a blood flow rate ≥ 250 ml/min Patient with micro inflammation, i.e an average CRP between 5 and 20 mg/L on the two last check-up of CRP Patient informed of the study and having signed the inform consent. Exclusion criteria : Underage patient Subjects who are pregnant or planning to become pregnant during the study Patient with an infection influencing the Hb level
Patient with an Iron deficiency showed with :
Transferin saturation < 20 % and/or Ferritin < 100 µg/L, Hemo transfusion in the last two months Patient treated by HF, HDF, biofiltration Patient with infectious risks Subjects who participated in a clinical study involving dialyzers in the last two months
Criteria of exit :
Patient wish Medical decision Hemo transfusion Departure for another dialysis center Transplantation Death
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViE High flux dialyzer | Experimental | vitamin E coated polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for the patient suffering from acute or chronic renal failure |
|
| Leoceed H high flux dialyzer | Active Comparator | polysulfone membrane manufactured by Asahi Kasei Medical, with CE mark and intended for use in hemodialysis for patient suffering from acute or chronic renal failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIE high flux dialyzer | Device | Asssesment of the therapeutic effect of the vitamin E coating |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the well-known inflammatory marker : High sensibility-CRP | Decrease of the CRP marker due the use of vitamin E coated dialyzer | one year with a follow-up of three months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | Evolution of the following inflammatory markers : IL-6, TNFalpha, fibrinogen, antibodies anti-LDLox | one year with a follow-up of three months |
| Anemia parameters | Evolution of Hemoglobin and ERI |
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Inclusion Criteria:
Exclusion Criteria:
Transferin saturation < 20 % and/or Ferritin < 100 µg/L,
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| Name | Affiliation | Role |
|---|---|---|
| Jean Paul CRISTOL, Doctor | AIDER association, clinique Jacques Mirouze 191 ave du Doyen Giraud 34295 Montpellier cedex 5 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDER | Montpellier | Occitanie | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22956433 | Result | Bargnoux AS, Cristol JP, Jaussent I, Chalabi L, Bories P, Dion JJ, Henri P, Delage M, Dupuy AM, Badiou S, Canaud B, Morena M. Vitamin E-coated polysulfone membrane improved red blood cell antioxidant status in hemodialysis patients. J Nephrol. 2013 May-Jun;26(3):556-63. doi: 10.5301/jn.5000195. Epub 2012 Sep 4. |
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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 multicenter controlled and randomized protocol study
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| Leoceed H high flux dialyzer | Device | Use of the Leoceed H dialyzer during one year per patient enrolled in the control group |
|
| one year with a follow-up of three months |
| Nutritional Parameters | Albumin and pre-albumin parameters | one year with a follow-up of three months |
| 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 |