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OpenTrials
Completed

NCT Number: NCT00337831

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

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).

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Gambro Corporate Research, Sweden

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 16, 2006
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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