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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445366

Contacts
Contact: Raymond Vanholder, PhD, MD raymond.vanholder@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Raymond Vanholder, MD, PhD       raymond.vanholder@ugent.be   
Principal Investigator: Raymond Vanholder, PhD, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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 September 30, 2014