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

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 Overview

• Status: Unknown
• Conditions: Catheter-related Infection
• Intervention / Treatment: Procedure: blood levels

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Isabel Spriet, PharmD PhD; Phone Number: 0032 16 34 30 80; Email: isabel.spriet@uzleuven.be
• Study Contact Backup: Name: Jan Verhaegen, MD PhD; Phone Number: 0032 16 33 22 11; Email: jan.verhaegen@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for catheter related infection with methicillin-resistant coagulase-negative staphylococci (MR-CNS) and treated with systemic vancomycin in combination with vancomycin antibiotic lock via central venous port device.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vancomycin cohort	Procedure: blood levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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/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.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Estimate): August 9, 2012
• Last Update Submitted That Met QC Criteria: August 8, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: vancomycin; TDM; levels; central venous port device; peripherally obtained levels; dose adjustments
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections
• Other Study ID Numbers: S54585