Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Device: High volume post dilution hemodiafiltration
* Device: high flux hemodialysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with end-stage renal disease<br> | Device: High volume post dilution hemodiafiltration<br>* 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.<br>Device: high flux hemodialysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. | 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). | During 4 hours | 
| Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. | 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 HD. Pre to post dialysis during 8h high flux HD. | During 8 hours |