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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00262353
Other study ID # 2004/416
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information

Verified date July 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system


Description:

After inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. In week 4, day 2, patients will be treated once with the Prometheus artificial hepatic system or with high-flux dialysis. The other days low-flux kidneys will be used. Week 5 and 6 are a wash-out period. Week 7 is identical to week 4 but the other system than in week 4 is used. Blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stable patients - At least 3 months on dialysis - Arterio-venous fistula Exclusion Criteria: - Diabetic patients - Malignancies - Acute illnesses

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dialysis with different artificial devices


Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of the concentration of protein-bound toxins after treatment with different artificial devices
Secondary Determination of the kinetics of protein-bound toxins after treatment with different artificial devices
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