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Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Catheter-related Infection

Intervention: blood levels (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Isabel Spriet, PharmD PhD, Principal Investigator, Affiliation: Pharmacy Dpt, University Hospitals Leuven
Jan Verhaegen, MD PhD, Study Chair, Affiliation: Medical Diagnostic Sciences, University Hospitals Leuven
Hans Prenen, MD PhD, Study Chair, Affiliation: Digestive ONcology, University Hosptials Leuven
Willy Peetermans, MD PhD, Study Chair, Affiliation: Internal Medicine, University Hospitals Leuven
Ludo Willems, PharmD PhD, Study Chair, Affiliation: Pharmacy Dpt., University Hosptials Leuven

Overall contact:
Isabel Spriet, PharmD PhD, Phone: 0032 16 34 30 80, Email: isabel.spriet@uzleuven.be

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.

Clinical Details

Official title: Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients,

- having central venous port device,

- treated with systemic vancomycin in combination with vancomycin antibiotic lock

Exclusion Criteria:

- pregnant women,

- children,

- patients with 'do not resuscitate' (DNR) code

Locations and Contacts

Isabel Spriet, PharmD PhD, Phone: 0032 16 34 30 80, Email: isabel.spriet@uzleuven.be

Additional Information

Starting date: September 2012
Last updated: August 8, 2012

Page last updated: August 23, 2015

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