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

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

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Source Universitaire Ziekenhuizen 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.

Overall Status Terminated
Start Date June 2014
Completion Date September 30, 2018
Primary Completion Date October 1, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 10
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Extensive flushing of the port catheter

Description: The port catheter will be flushed extensively with sodium chloride 0.9% before blood sampling. Blood sampling will occur through the central catheter and peripherally simultaneously.

Arm Group Label: Patients with port catheter: flushing

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Isabel Spriet, PharmD PhD Principal Investigator Universitaire Ziekenhuizen Leuven
Location
Facility: Universitaire Ziekenhuizen Leuven
Location Countries

Belgium

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universitaire Ziekenhuizen Leuven

Investigator Full Name: Isabelle Spriet

Investigator Title: PharmD, PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Patients with port catheter: flushing

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov