influence of the vitamine e coated dialyzer on inflammation and anemia

Conditions: End Stage Renal Disease; Inflammation

Summary: 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

Eligibility criteria:
inclusion criteria: * adult esrd patient, whatever the origin, treated by hd, thrice a week for about 4 hours and hemo dynamically well balanced * 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, * patients having received an 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