Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543940
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Pharmacokinetics Vancomycin CVVHDF With oXiris Membrane
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacokinetics of Vancomycin in Patients Receiving Continuous Veno-Venous Hemodiafiltration CVVHDF With the Absorptive oXiris Membrane
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a general pharmacokinetic investigation of vancomycin in patients receiving continuous veno-venous hemodiafiltration CRRT with the oXiris membrane This membrane offers the added benefit of absorbing inflammatory cytokines In vitro studies show that vancomycin is reduced by around 20 percent in patients using the AN69ST membrane which is part of the oXiris membranes structure However there is currently a lack of in vivo studies demonstrating the impact of the oXiris membrane on vancomycin levels Therefore the hypothesis of this study is that vancomycin is also reduced by absorption in the oXiris membrane This study measures the levels of vancomycin in these patients to determine the pharmacokinetic parameters
Detailed Description:
This study monitors the levels of the maintenance dose of vancomycin in patients receiving continuous renal replacement therapy CRRT with the CVVHDF mode using the oXiris membrane Blood samples were drawn from the A-line at the following time points 0 predose 2 3 4 5 6 8 and 12 hours after drug administration The area under the curve AUC of the drug was calculated using the Phoenix WinNonlin program Additionally we reported the pharmacokinetic profile of this drug in patients with acute kidney injury AKI undergoing CRRT with the oXiris membrane
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