Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

Launched by HEMOTECH · Aug 22, 2017

Keywords

ClinConnect Summary

Medical devices studied :

* Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany
* Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany
* VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan
* Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia

These hemodialyzers are EC marked and are used in their own indications.

Schema

Details of the cross-over plan :

8 patients will be treated successively with the...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
• • Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
• • Patient treated before with high permeability membrane
• • Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
• • Patient treated with a high surface area dialyzer ≥ 1,8 m²
• • Patient covered by the social French health organism
• • Patient informed of the study goals and having signed the informed consent
• Exclusion Criteria:
• • Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
• • Patient with a fast progressive chronic disease
• • Patient with an uncontrolled anemia
• • Patient refusing to sign the informed consent
• • Pregnant or nursing patient
• • Pediatric patient
• • Patient under tutorship