Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262353
Status:
WITHDRAWN
Last Update Posted:
2021-07-02
First Post:
2005-12-04
Brief Title:
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Elimination of Protein-bound Uremic Retention Solutes by Prometheus Artificial Hepatic System Versus Conventional Dialysis
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study never started because of safety alerts in literature regarding the topic to be examined
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of the efficacy of dialysis by conventional dialysis versus Prometheus artificial hepatic system
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None