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

NCT ID: NCT03720132

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Catheter Related Blood Stream Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Extensive flushing of the port catheter

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Spriet

PharmD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel Spriet, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 19569969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21039771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19489710 (View on PubMed)

Other Identifiers

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S20140519

Identifier Type: -

Identifier Source: org_study_id

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