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

Not Applicable

Terminated

• Conditions: Catheter Related Blood Stream Infections
• Interventions: Procedure: Extensive flushing of the port catheter

• Registration Number: NCT03720132
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2015-10-01
• Study First Submitted: 2016-11-29
• Study Completion: 2018-09-30
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with port catheter: flushing	Extensive flushing of the port catheter	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.

Primary Outcome Measures

Name	Time	Method
Vancomycin trough levels via port catheter and peripheral vein	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.

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium