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Trial record 66 of 528 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT03720132
Recruitment Status : Terminated (Emerging evidence made the trial unnecessary.)
First Posted : October 25, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Isabelle Spriet, 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.

Condition or disease Intervention/treatment Phase
Catheter Related Blood Stream Infections Procedure: Extensive flushing of the port catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
Study Start Date : June 2014
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with port catheter: flushing
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
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 Measures :
  1. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720132


Locations
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Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Isabel Spriet, PharmD PhD Universitaire Ziekenhuizen Leuven

Publications:
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Responsible Party: Isabelle Spriet, PharmD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03720132     History of Changes
Other Study ID Numbers: S20140519
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by Isabelle Spriet, Universitaire Ziekenhuizen Leuven:
Vancomycin
Therapeutic drug monitoring
Catheter related blood stream infections
Additional relevant MeSH terms:
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Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents