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

• Conditions: Catheter-related Infection
• Interventions: Procedure: blood levels

• Registration Number: NCT01661361
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-20
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-08
• Last Update Submitted: 2012-08-08
• Study First Posted: 2012-08-09
• Last Update Posted: 2012-08-09
• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vancomycin cohort	blood levels	-

Primary Outcome Measures

Name	Time	Method
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	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.