Dialysis Amyloidosis, Dialysis Related Complication, End Stage Renal Disease
Conditions
Keywords
dialyzer, beta2-microglobilin, myoglobin
Brief summary
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.
Interventions
DEVICETheranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
DEVICEElisio-21H
hemodialysis with Elisio-21H dialyzer
Sponsors
Baxter Healthcare Corporation
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Removal of myoglobin | After 3 months | myoglobin Reduction ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Removal of urea | After 3 months | Reduction ratio and clearances of urea |
| Removal of creatinine | After 3 months | Reduction ratio and clearances of creatinine |
| Removal of interleukin 6 | After 3 months | Reduction ratio and clearances of interleukin 6 |
| Removal of IL-1beta | After 3 months | Reduction ratio and clearances of IL-1beta |
| Removal of TNF alpha | After 3 months | Reduction ratio and clearances of TNF alpha |
| Removal of leptin | After 3 months | Reduction ratio and clearances of leptin |
| Removal of alpha 1 microglobulin | After 3 months | Reduction ratio and clearances of alpha 1 microglobulin |
| Removal of retinol binding protein | After 3 months | Reduction ratio and clearances of retinol binding protein |
| Removal of hyaluronic acid | After 3 months | Reduction ratio and clearances of hyaluronic acid |
| Removal of FGF 23 (fibroblast growth factor 23) | After 3 months | Reduction ratio and clearances of FGF 23 |
| Removal of prolactin | After 3 months | Reduction ratio and clearances of prolactin |
| Removal of free light chain kappa | After 3 months | Reduction ratio and clearances of free light chain kappa |
| Removal of beta2 microglobulin | After 3 months | Reduction rate and clearances of beta2 microglobulin |
| comparison of pre dialysis level of hepcidin | After 3 months | comparison of average of pre dialysis level of hepcidin |
| comparison of pre dialysis level of superoxide dismutase | After 3 months | comparison of average of pre dialysis level of superoxide dismutase |
| comparison of pre dialysis level of isoprostan | After 3 months | comparison of average of pre dialysis level of isoprostan |
| comparison of pre dialysis level of human oxidized LDL | After 3 months | comparison of average of pre dialysis level of human oxidized LDL |
| comparison of pre dialysis level of albumin | After 3 months | comparison of average of pre dialysis level of albumin |
| comparison of pre dialysis level of prealbumin | After 3 months | comparison of average of pre dialysis level of prealbumin |
| comparison of post dialysis level of albumin | After 3 months | comparison of average of post dialysis level of albumin |
| comparison of level of middle molecules and albumin in the dialysate | After 3 months | comparison of average level of midlle molecules and albumin in dialysate |
| comparison of use of erythrpoietin | After 3 months | Comparison of the erythropoietin resistance index |
| comparison of hemoglobin levels | After 3 months | comparison of average of predialysis hemoglobin levels |
| comparison of pre dialysis level of CRP | After 3 months | comparison of average of pre dialysis level of CRP |
| comparison of pre dialysis level of SAA | After 3 months | comparison of average of pre dialysis level of SAA |
| Removal of free light chain lambda | After 3 months | Reduction ratio and clearances of free light chain lambda |
Countries
France
Outcome results
None listed