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
|Condition or disease||Intervention/treatment||Phase|
|Catheter Related Blood Stream Infections||Procedure: Extensive flushing of the port catheter||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Universitaire Ziekenhuizen Leuven|
|Leuven, Belgium, 3000|
|Principal Investigator:||Isabel Spriet, PharmD PhD||Universitaire Ziekenhuizen Leuven|