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

Not Applicable

Completed

• Conditions: Chronic Renal Failure

• Registration Number: NCT00337831
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Primary Completion: 2007-02
• Study Completion: 2007-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium