Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
Recruitment status was: Not yet recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices|
- comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L [ Time Frame: central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661361
|Principal Investigator:||Isabel Spriet, PharmD PhD||Pharmacy Dpt, University Hospitals Leuven|
|Study Chair:||Jan Verhaegen, MD PhD||Medical Diagnostic Sciences, University Hospitals Leuven|
|Study Chair:||Hans Prenen, MD PhD||Digestive ONcology, University Hosptials Leuven|
|Study Chair:||Willy Peetermans, MD PhD||Internal Medicine, University Hospitals Leuven|
|Study Chair:||Ludo Willems, PharmD PhD||Pharmacy Dpt., University Hosptials Leuven|