Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

This study has been completed.
Sponsor:
Collaborator:
Gambro Corporate Research, Sweden
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00337831
First received: June 15, 2006
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).


Condition Intervention
Chronic Renal Failure
Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood? [ Time Frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. ] [ Designated as safety issue: No ]
  • To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins? [ Time Frame: Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
    Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable on hemodialysis >= 6 months
  • of which presently on high-flux HD >= 1 month
  • 18 years < age < 85 years
  • blood flow rate >= 300ml/min

Exclusion Criteria:

  • expected survival < 1 year
  • expected transplant within < 1 year
  • infectious diseases
  • pregnancy
  • chronic inflammation condition
  • treated with single needle dialysis
  • presently treated with hemodiafiltration or low-flux hemodiafiltration
  • expected intradialytic body weight gain >= 4kg
  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: NCT00337831

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Gambro Corporate Research, Sweden
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Natalie Meert, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00337831     History of Changes
Other Study ID Numbers: 2006/127
Study First Received: June 15, 2006
Last Updated: June 29, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 30, 2014