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

NCT ID: NCT00337831

Last Updated: 2011-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gambro Corporate Research, Sweden

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Raymond Vanholder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2006/127

Identifier Type: -

Identifier Source: org_study_id