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

Primary Purpose

Catheter Related Blood Stream Infections

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Extensive flushing of the port catheter
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Catheter Related Blood Stream Infections focused on measuring Vancomycin, Therapeutic drug monitoring, Catheter related blood stream infections

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaire Ziekenhuizen Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with port catheter: flushing

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2016
Last Updated
October 25, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03720132
Brief Title
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Official Title
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Emerging evidence made the trial unnecessary.
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Blood Stream Infections
Keywords
Vancomycin, Therapeutic drug monitoring, Catheter related blood stream infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with port catheter: flushing
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Extensive flushing of the port catheter
Intervention 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.
Primary Outcome Measure Information:
Title
Vancomycin trough levels via port catheter and peripheral vein
Description
Vancomycin trough levels will be determined, both on peripheral blood and blood taken via the port catheter and will be compared.
Time Frame
At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Spriet, PharmD PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
19569969
Citation
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. Erratum In: Clin Infect Dis. 2009 Nov 1;49(9):1465.
Results Reference
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PubMed Identifier
21039771
Citation
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.
Results Reference
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PubMed Identifier
19489710
Citation
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. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.
Results Reference
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Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

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