Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure
Eligibility 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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
Full Information
NCT ID
NCT00337831
First Posted
June 15, 2006
Last Updated
June 29, 2011
Sponsor
University Hospital, Ghent
Collaborators
Gambro Corporate Research, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00337831
Brief Title
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Official Title
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
Collaborators
Gambro Corporate Research, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
Intervention Description
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
Primary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
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