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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337831
First Posted: June 16, 2006
Last Update Posted: June 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gambro Corporate Research, Sweden
Information provided by:
University Hospital, Ghent
June 15, 2006
June 16, 2006
June 30, 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. ]
  • 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. ]
  • 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
Intervention Model: Crossover Assignment
Masking: None (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.
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*   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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00337831
2006/127
No
Not Provided
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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