Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
NCT03262272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2019-02-21
Summary
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.
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.
Conditions
Interventions
- DEVICE
-
VIE A Hemodialyzer
polysulfon membrane coated with vitamin E
- DEVICE
-
Rexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
- DEVICE
-
Leoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
- DEVICE
-
Polypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization
Sponsors & Collaborators
-
Hemotech
lead INDUSTRY
Principal Investigators
-
Jean Paul CRISTOL, Professor · University Hospital, Montpellier
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-21
- Primary Completion
- 2018-07-31
- Completion
- 2018-10-31
Countries
- France
Study Locations
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