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

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337831
• Other study ID #: 2006/127
• Status: Completed
• Phase: N/A
• First received: June 15, 2006
• Last updated: June 29, 2011
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Procedure:
• Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Gambro Corporate Research, Sweden

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No

External Links

•   Website University Hospital Ghent