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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
314
A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg\*h/L
Vancomycin treatment
Erasme
Brussels, Brussels Capital, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
Cliniques universitaires de Saint Luc
Brussels, Belgium
Hopital universitaire de Reine Fabiola
Brussels, Belgium
Proportion of patients reaching target 24hAUC/MIC
therapeutic AUC/MIC target range is 400-600
Time frame: 24 to 48 hours after start vancomycin treatment
Proportion of patients with (worsening) acute kidney injury during vancomycin treatment
AKI categories are defined according to the neonatal and pediatric RIFLE criteria
Time frame: from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
therapeutic AUC/MIC target range is 400-600
Time frame: 48-72 hours after start vancomycin treatment
Time to clinical cure
Time to clinical cure is defined as the time interval (in days) from start to completion of the vancomycin vancomycin treatment, without recommencement of antibiotics for the same indication within 48h after stop.
Time frame: 30 day study period
Ward unit length-of-stay
Ward unit length-of-stay is calculated from day of ward unit admission to day of ward unit discharge.
Time frame: 30 day study period
Hospital length-of-stay
Hospital unit length-of-stay is calculated from day of hospital admission to day of hospital discharge.
Time frame: 30 day study period
30 day all cause mortality
30 day all cause mortality is measured 30 days after randomisation.
Time frame: 30 day study period
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UZ Brussel
Brussels, Belgium
Ghent University Hospital
Ghent, Belgium
UZ Leuven
Leuven, Belgium