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

Poitiers University Hospital

Status

Completed

Conditions

Dialysis Related Complication

Dialysis Amyloidosis

End Stage Renal Disease

Treatments

Device: Elisio-21H

Device: Theranova-500 dialyzer

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03211676

2016-A01679-42

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ).