Precision Dosing of Vancomycin in Critically Ill Children
Precision Dosing of Vancomycin in Critically Ill Children
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.
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.
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