Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model (PIC-AMI)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Pharmacokinetics

Study type: Observational

Funder types: Other

Identifiers

NCT03683511

RC14_0121

Details and patient eligibility

About

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.

Full description

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 Nîmes (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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients treated with amikacin for sepsis in one of the participating ICU will be included.

Exclusion criteria

• patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.