Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer

Poitiers University Hospital49 enrolled

Overview

The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis. Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out. Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease Dialysis Related Complication Dialysis Amyloidosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months, * Patient under dialyser Elisio-21H ™ for more than 3 months * Patient including the protocol scheme and able to comply with it * Free subject, without guardianship or curatorship or subordination * Patients benefiting from a Social Security scheme or benefiting from it through a third party * Non-opposition given by the patient after clear and fair information on the study Exclusion Criteria: * Age \<18 years * Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP\> 60 mg / L) * Patient following another protocol of research or period of exclusion of another protocol * Patients not benefiting from a Social Security scheme or not benefiting from it through a third party * Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies . * Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).

Outcomes

Primary Outcomes

Removal of myoglobin

myoglobin Reduction ratio.

Time frame: After 3 months

Secondary Outcomes

Removal of beta2 microglobulin

Reduction rate and clearances of beta2 microglobulin

Time frame: After 3 months

Removal of urea

Reduction ratio and clearances of urea

Time frame: After 3 months

Removal of creatinine

Reduction ratio and clearances of creatinine

Time frame: After 3 months

Removal of interleukin 6

Reduction ratio and clearances of interleukin 6

Time frame: After 3 months

Removal of IL-1beta

Reduction ratio and clearances of IL-1beta

Time frame: After 3 months

Removal of TNF alpha

Reduction ratio and clearances of TNF alpha

Time frame: After 3 months

Removal of leptin

Reduction ratio and clearances of leptin

Time frame: After 3 months

Removal of alpha 1 microglobulin

Reduction ratio and clearances of alpha 1 microglobulin

Time frame: After 3 months

Removal of retinol binding protein

Reduction ratio and clearances of retinol binding protein

Time frame: After 3 months

Removal of hyaluronic acid

Reduction ratio and clearances of hyaluronic acid

Time frame: After 3 months

Removal of FGF 23 (fibroblast growth factor 23)

Reduction ratio and clearances of FGF 23

Time frame: After 3 months

Removal of prolactin

Reduction ratio and clearances of prolactin

Time frame: After 3 months

Removal of free light chain kappa

Reduction ratio and clearances of free light chain kappa

Time frame: After 3 months

Removal of free light chain lambda

Reduction ratio and clearances of free light chain lambda

Time frame: After 3 months

comparison of pre dialysis level of hepcidin

comparison of average of pre dialysis level of hepcidin

Time frame: After 3 months

comparison of pre dialysis level of superoxide dismutase

comparison of average of pre dialysis level of superoxide dismutase

Time frame: After 3 months

comparison of pre dialysis level of isoprostan

comparison of average of pre dialysis level of isoprostan

Time frame: After 3 months

comparison of pre dialysis level of human oxidized LDL

comparison of average of pre dialysis level of human oxidized LDL

Time frame: After 3 months

comparison of pre dialysis level of albumin

comparison of average of pre dialysis level of albumin

Time frame: After 3 months

comparison of pre dialysis level of prealbumin

comparison of average of pre dialysis level of prealbumin

Time frame: After 3 months

comparison of post dialysis level of albumin

comparison of average of post dialysis level of albumin

Time frame: After 3 months

comparison of level of middle molecules and albumin in the dialysate

comparison of average level of midlle molecules and albumin in dialysate

Time frame: After 3 months

comparison of use of erythrpoietin

Comparison of the erythropoietin resistance index

Time frame: After 3 months

comparison of hemoglobin levels

comparison of average of predialysis hemoglobin levels

Time frame: After 3 months

comparison of pre dialysis level of CRP

comparison of average of pre dialysis level of CRP

Time frame: After 3 months

comparison of pre dialysis level of SAA

comparison of average of pre dialysis level of SAA

Time frame: After 3 months

Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes