Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
NCT ID: NCT03262272
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2016-11-21
2018-10-31
Brief Summary
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To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.
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Detailed Description
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* 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 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center.
Number of patients :
32 (8 patients per center (4 centers))
Duration :
One week per dialyzer
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Hemodialysis
patients treated by conventionnal hemodialysis
VIE A Hemodialyzer
polysulfon membrane coated with vitamin E
Rexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
Leoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
Polypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization
Hemodiafiltration post dilution
patients treated by HDF post-dilution
VIE A Hemodialyzer
polysulfon membrane coated with vitamin E
Rexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
Leoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
Polypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization
Interventions
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VIE A Hemodialyzer
polysulfon membrane coated with vitamin E
Rexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
Leoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
Polypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Hemotech
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Paul CRISTOL, Professor
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
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AIDER-Lapeyronie
Montpellier, , France
Countries
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References
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Kokubo K, Kurihara Y, Kobayashi K, Tsukao H, Kobayashi H. Evaluation of the Biocompatibility of Dialysis Membranes. Blood Purif. 2015;40(4):293-7. doi: 10.1159/000441576. Epub 2015 Nov 17.
Maduell F, Moreso F, Mora-Macia J, Pons M, Ramos R, Carreras J, Soler J, Torres F; study group ESHOL. ESHOL study reanalysis: All-cause mortality considered by competing risks and time-dependent covariates for renal transplantation. Nefrologia. 2016;36(2):156-63. doi: 10.1016/j.nefro.2015.10.007. Epub 2015 Dec 8. English, Spanish.
Other Identifiers
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BIOMODAL 2016-A01122-49
Identifier Type: -
Identifier Source: org_study_id
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