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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00337831
Enrollment
17
Registered
2006-06-16
Start date
2006-05-31
Completion date
2007-05-31
Last updated
2011-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

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).

Interventions

PROCEDUREPerformance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.

Sponsors

Gambro Corporate Research, Sweden
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026