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

June 29, 2011 updated by: University Hospital, Ghent

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).

Study Overview

Status

Completed

Conditions

Chronic Renal Failure

Intervention / Treatment

Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Ghent, Belgium, 9000
    - University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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? 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.	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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Gambro Corporate Research, Sweden

Investigators

Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

website University Hospital Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria