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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
History of Changes

June 15, 2006
June 29, 2011
May 2006
February 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
  • To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins?
Complete list of historical versions of study NCT00337831 on ClinicalTrials.gov Archive Site
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Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

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).
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Renal Failure
Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
May 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00337831
2006/127
No
Natalie Meert, University Hospital Ghent
University Hospital, Ghent
Gambro Corporate Research, Sweden
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
University Hospital, Ghent
June 2011

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