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

NCT03720132 | Terminated

• 1 other identifier: S20140519
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Blood Stream Infections

Keywords

Vancomycin; Therapeutic drug monitoring; Catheter related blood stream infections

Outcome Measures

Primary Outcomes (1)

• Vancomycin trough levels via port catheter and peripheral vein

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

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

Study Arms (1)

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.

Procedure: Extensive flushing of the port catheter

Interventions

Extensive flushing of the port catheter PROCEDURE

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.

Patients with port catheter: flushing

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Age \> 18 years
• Active downgrading of care

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

• Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877.

  PMID: 19569969 BACKGROUND

• Wright DF, Al-Sallami HS, Jackson PM, Reith DM. Falsely elevated vancomycin plasma concentrations sampled from central venous implantable catheters (portacaths). Br J Clin Pharmacol. 2010 Nov;70(5):769-72. doi: 10.1111/j.1365-2125.2010.03749.x. No abstract available.

  PMID: 21039771 BACKGROUND

• Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.

  PMID: 19489710 BACKGROUND

Study Officials

• Isabel Spriet, PharmD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: October 25, 2018
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: September 30, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

BE (1)