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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01661361
Enrollment
15
Registered
2012-08-09
Start date
2012-09-30
Completion date
2012-12-31
Last updated
2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-related Infection

Keywords

vancomycin, levels, central venous port device, peripherally obtained levels, dose adjustments, TDM

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.

Interventions

PROCEDUREblood levels

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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/Lcentral 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.

Contacts

Primary ContactIsabel Spriet, PharmD PhD
isabel.spriet@uzleuven.be0032 16 34 30 80
Backup ContactJan Verhaegen, MD PhD
jan.verhaegen@uzleuven.be0032 16 33 22 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026