Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
1 other identifier
interventional
17
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 15, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 30, 2011
June 1, 2011
9 months
June 15, 2006
June 29, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood?
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?
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.
Interventions
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
Eligibility Criteria
You may qualify if:
- stable on hemodialysis \>= 6 months
- of which presently on high-flux HD \>= 1 month
- years \< age \< 85 years
- blood flow rate \>= 300ml/min
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Gambro Corporate Research, Swedencollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Vanholder, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 15, 2006
First Posted
June 16, 2006
Study Start
May 1, 2006
Primary Completion
February 1, 2007
Study Completion
May 1, 2007
Last Updated
June 30, 2011
Record last verified: 2011-06