Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End-stage Renal Disease |
Device: High volume post dilution hemodiafiltration Device: high flux hemodialysis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis |
- Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. [ Time Frame: During 4 hours ] [ Designated as safety issue: No ]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).
- Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. [ Time Frame: During 8 hours ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Patients with end-stage renal disease |
Device: High 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.
Device: high 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Raymond Vanholder, PhD, MD | raymond.vanholder@ugent.be |
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Raymond Vanholder, MD, PhD raymond.vanholder@ugent.be | |
| Principal Investigator: Raymond Vanholder, PhD, MD | |
| Principal Investigator: | Raymond Vanholder, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01445366 History of Changes |
| Other Study ID Numbers: | 2011/591 |
| Study First Received: | September 22, 2011 |
| Last Updated: | February 1, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |
ClinicalTrials.gov processed this record on May 21, 2013