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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01661361
• Collaborator: (none)
• Enrollment: 15
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-related Infection	Procedure: blood levels

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
vancomycin cohort	Procedure: blood levels

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universitaire Ziekenhuizen 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Isabelle Spriet, PharmD, PhD, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT01661361
• Other Study ID Numbers: S54585
• First Posted: Aug 9, 2012
• Last Update Posted: Aug 9, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Isabelle Spriet, PharmD, PhD, Universitaire Ziekenhuizen Leuven: vancomycin; levels; central venous port device; peripherally obtained levels; dose adjustments; TDM
• Additional relevant MeSH terms: Catheter-Related Infections

Study Results

No Results Posted as of Aug 9, 2012