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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nīmes | OTHER |
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The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.
French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of NĂ®mes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.
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| Measure | Description | Time Frame |
|---|---|---|
| amikacin infusion | Target is defined as 8 times x Minimal Inhibatory Concentration for MIC = 4 mg/L and MIC = 8 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables. | one hour after beginning of infusion.ed |
| Measure | Description | Time Frame |
|---|---|---|
| maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration. | Target is 2.5 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables. | 24 hours after beginning of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with amikacin for sepsis ou septic shock in the medical intensive care unit of Nantes,France or in an ICU of Nîmes, France will be recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26429564 | Background | Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1. |
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