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Clinical Trials/NCT03720132
NCT03720132TerminatedNot Applicable

Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

Universitaire Ziekenhuizen KU Leuven1 site in 1 country10 target enrollmentStarted: June 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
Vancomycin trough levels via port catheter and peripheral vein

Study Overview

Brief Summary

The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

Detailed Description

In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.

Flushing will be done with sodium chloride 0.9 % solution.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Pediatric patients with a port catheter
  • •Treated with systemic vancomycin and/or vancomycin "lock"

Exclusion Criteria

  • •Age > 18 years
  • •Active downgrading of care

Arms & Interventions

Patients with port catheter: flushing

Experimental

In patients with a catheter-related blood stream infection (CRBSI) and a port catheter, being treated with vancomycin intravenously, we will flush the catheter with 30 ml of sodium chloride 0.9 % prior to blood sampling to determine vancomycin concentrations, in order to decrease residuel vancomycin in the port.

Intervention: Extensive flushing of the port catheter (Procedure)

Outcomes

Primary Outcomes

Vancomycin trough levels via port catheter and peripheral vein

Time Frame: At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose

Vancomycin trough levels will be determined, both on peripheral blood and blood taken via the port catheter and will be compared.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Isabelle Spriet

PharmD, PhD

Universitaire Ziekenhuizen KU Leuven

Study Sites (1)

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