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Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

Sponsor
University Hospital, Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT01445366
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
44
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High volume post dilution hemodiafiltration
  • Device: high flux hemodialysis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
Study Start Date :
Apr 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. [During 8 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 HD. Pre to post dialysis during 8h high flux HD.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 University Hospital Ghent Ghent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01445366
Other Study ID Numbers:
  • 2011/591
First Posted:
Oct 3, 2011
Last Update Posted:
Dec 5, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Dec 5, 2014