End-stage Renal Disease
Conditions
Brief summary
This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek. During one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min. During the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of 200mL/min and a dialysate flow of 500mL/min. The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line. At the dialysate outlet line, partial dialysate collection is performed at the outlet line. Blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes. These data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution HDF and high flux HD.
Interventions
DEVICEHigh volume post dilution hemodiafiltration
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
DEVICEhigh flux hemodialysis
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months. * No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter) * Double needle/lumen vascular access * No ongoing infection * Singed informed consent form
Exclusion criteria
* Inclusion criteria not met * Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction (PCR)) * Pregnancy * Unstable clinical condition (e.g. cardiac or vascular instability) * Known coagulation problems * Patients participating in another study interfering with the planned study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. | During 4 hours | Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with hemodialysis (HD). Pre to post dialysis during 4h post dilution hemodiafiltration (HDF). |
Countries
Belgium
Outcome results
None listed