chronic kidney disease hemodialysis
Conditions
Interventions
The intervention in this study consists out of the randomisation of the three
dialysis modalities (A) post-dilution HDF with ULTRACONTROL
(B) post-dilution
HDF with volume control and (C) standard high-flux hemodialysis. This
randomisation will only be carried out for the second treatment of week 2 to
week 4. For all other treatments
Sponsors
Gambro Lundia AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1 on dialysis since 3 months or longer 2 stable on on-line postdilution HDF therapy since at least 1 month 2a of which at least one week in ULTRACONTROL mode using Polyflux H dialyzer 2b known on what total UF rate in relation to QB is possible during volume control mode when Polyflux H dialyzer is used, without having monitor TMP alarms 3 regularly achieving a blood flow rate of 250 ml/min or more 4 giving written consent to participate
Exclusion criteria
Exclusion criteria: 1 Age 5 hours 4 Showing unstable blood flow rates and/or regularly showing access recirculation exceeding 5%. 5 Treatments in single needle mode 6 Expected to show poor compliance to dialysis prescription 7 Known HIV, HBV, or HCV infection 8 Known coagulation disorder 9 Pregnant women, nursing mothers and women planning a pregnancy during the course of the study 10 Patients under guardianship 11 Participation in other studies that could interfere with the objectives of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the randomized, cross-over comparison between treatment modes is the pre- to post-dialysis reduction in plasma b2-microglobulin level | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. As secondary endpoints, the following indices of treatment efficacy will be used a. blood urea reduction from pre- to post-dialysis b. Diascan Kt/V using Watson V as input c. phosphate reduction from blood levels pre- and post-dialysis d. uric acid reduction from blood levels pre- and post-dialysis e. CRP reduction from blood levels pre- and post-dialysis f. removal of complement factor D, based on changes in plasma level from pre- to post-dialysis g. removal of cystatin C, based on changes in plasma level from pre- to post-dialysis h. b2m, cystatin C, and factor D mass in spent dialysate i. albumin mass in spent dialysate | — |
Countries
Netherlands
Outcome results
None listed