Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01445366
First received: September 22, 2011
Last updated: February 1, 2013
Last verified: February 2013

September 22, 2011
February 1, 2013
April 2012
July 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01445366 on ClinicalTrials.gov Archive Site
Not Provided
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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
Experimental: Patients with end-stage renal disease
Interventions:
  • Device: High volume post dilution hemodiafiltration
  • Device: high flux hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Raymond Vanholder, PhD, MD raymond.vanholder@ugent.be
Belgium
 
NCT01445366
2011/591
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP