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

NCT01661361 | Unknown

• 1 other identifier: S54585
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Catheter-related Infection

Keywords

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

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

vancomycin cohort

Procedure: blood levels

Interventions

blood levels PROCEDURE

vancomycin cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adult patients,
• having central venous port device,
• treated with systemic vancomycin in combination with vancomycin antibiotic lock

You may not qualify if:

• pregnant women,
• children,
• patients with 'do not resuscitate' (DNR) code

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

Oxygen Saturation

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Isabel Spriet, PharmD PhD

  Pharmacy Dpt, University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Isabel Spriet, PharmD PhD

CONTACT

0032 16 34 30 80; isabel.spriet@uzleuven.be

Jan Verhaegen, MD PhD

CONTACT

0032 16 33 22 11; jan.verhaegen@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 9, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 9, 2012

Record last verified: 2012-08