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

Catheter-related Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01661361
• Other study ID #: S54585
• Status: Not yet recruiting
• Phase: N/A
• First received: July 20, 2012
• Last updated: August 8, 2012
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Isabel Spriet, PharmD PhD
• Phone: 0032 16 34 30 80
• Email: isabel.spriet[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter-related Infection
• Catheter-Related Infections

Intervention

Procedure:
• blood levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No