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Samenvatting
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In de afgelopen periode hebben wij voorbereidingen getroffen voor het uitvoeren van de Right Dose, Right Now klinische trial. Hierin wordt bij patienten met ernstige sepsis de dosering van antibiotica gepersonaliseerd met behulp van onze AutoKinetics software. Deze geeft in real time doseringsadvies aan de behandelend intensivist met behulp van gegevens uit het elektronisch patiëntendossier.

Resultaten
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De voorbereidingen bestonden uit het doorontwikkelen van de software zodat deze adequaat communiceert met de elektronische patiënten dossiers, het kiezen van de best beschikbare doseringsmodellen en het verkrijgen van toestemming van de medisch ethische toetsingscommissie.

 

De voorbereidingen zijn inmiddels succesvol afgerond waardoor de klinische trial zal kunnen starten.

Samenvatting van de aanvraag

Samenvatting
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Sepsis remains a major healthcare problem. In the Netherlands, 15.000 patients develop severe sepsis each year and 30% of them will die, despite treatment in intensive care units (ICUs). Fast and adequate administration of antibiotics is crucial. However, antibiotic dosing is particularly difficult in the critically ill, as their pharmacokinetic profile is markedly disturbed. Still, doctors invariably use standard dosing schemes. This may cause drug-related toxicity because of overdosing, or treatment failure in case of underdosing.

 

Therefore, many hospitals rely on Therapeutic Drug Monitoring. However, availability is not universal, and especially lacking at the bedside. This is why we developed AutoKinetics (AutoK) software. AutoK has direct access to the large amount of patient data that is routinely collected in electronic patient records in ICUs, such as data on fluid balance and organ function. The software uses the data in pharmacokinetic models and thus allows for faster and more precise dosing advice. AutoK runs on the computer at the bedside. Thus, advice is readily available, even before treatment is started, and is continuously updated as disease and therapy evolve: true personalised dosing.

 

We believe that AutoK can improve antibiotic dosing, morbidity and mortality for severe sepsis. Therefore, we intend to study which pharmacokinetic models best predict antibiotic concentrations for three antibiotics using AutoK (ceftriaxone, vancomycin and meropenem). We will then use these in a two-center clinical trial. We will randomise patients with severe sepsis (n=42 per group, per antibiotic), for antibiotic dosing through AutoK or standard therapy. The primary endpoint is attainment of relevant PD targets. Secondary endpoints include morbidity, mortality, quality of life and length of stay. By reducing length of stay, AutoK can lead to a cost saving of more than €50 million per year, in addition to expected improvements for mortality and quality of life.

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