Precision Dosing of Vancomycin in Critically Ill Children (BENEFICIAL)

  • STATUS
    Recruiting
  • End date
    Apr 6, 2023
  • participants needed
    390
  • sponsor
    University Hospital, Ghent
Updated on 6 June 2022

Summary

The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.

Description

Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the critically ill child is challenging.

Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.

This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.

Details
Condition Vancomycin
Treatment Vancomycin, vancomycin model-informed precision dosing
Clinical Study IdentifierNCT04666948
SponsorUniversity Hospital, Ghent
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

age: 0-15 years
admitted to ICU or PHO unit
suspected or confirmed Gram positive infection
planned to start on intravenous intermittent or continuous infusion vancomycin treatment
informed consent signed by parents or legal representatives
not previously enrolled in this trial

Exclusion Criteria

extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.2. screening)
Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
patient death is deemed imminent and inevitable
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