Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01661361|
Recruitment Status : Unknown
Verified August 2012 by Isabelle Spriet, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : August 9, 2012
Last Update Posted : August 9, 2012
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.
|Condition or disease||Intervention/treatment|
|Catheter-related Infection||Procedure: blood levels|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
|vancomycin cohort||Procedure: blood levels|
- 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. ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661361
|Contact: Isabel Spriet, PharmD PhD||0032 16 34 30 firstname.lastname@example.org|
|Contact: Jan Verhaegen, MD PhD||0032 16 33 22 email@example.com|
|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|