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Catheter-related Infection | Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Catheter-related Infection research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Catheter-related Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:blood levels

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

vancomycin cohort

Study Status

Unknown status

Start Date: September 2012

Completed Date: December 2012

Phase: N/A

Type: Observational

Design:

Primary Outcome: 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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Isabel Spriet, PharmD PhD

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01661361

Discuss Flushing