Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT01661361
Status:
UNKNOWN
Last Update Posted:
2012-08-09
First Post:
2012-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recently, it was reported that when vancomycin levels are determined after port sampling, levels can be falsely increased potentially leading to wrong dose adjustments.
The investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L.
In this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock.
The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.
The investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L.
In this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock.
The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: