Status:
COMPLETED
Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
Lead Sponsor:
Hemotech
Conditions:
End Stage Renal Disease
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 profil...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03262272
Start Date
November 21 2016
End Date
October 31 2018
Last Update
February 21 2019
Active Locations (1)
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1
AIDER-Lapeyronie
Montpellier, France, 34295