Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock (AMINO BESTDOSE)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Shock, Septic

Treatments

Other: Amikacin dose optimization

Study type

Interventional

Funder types

Other

Identifiers

NCT04178148

NIMAO/2018-02/CR-01

Details and patient eligibility

About

Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient or their legal representative must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient has septic shock according to the SEPSIS-3 definition in the 24 hours preceding inclusion, regardless of the source of infection
Patient having already received a first dose of amikacin in the 22 preceding hours
Patient with an expectation of receiving at least 2 doses of amikacin
Patient with available amikacin therapeutic drug monitoring

Exclusion criteria

The subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study
The patient is pregnant, parturient or breastfeeding
Patient has a contra-indication or an allergy to treatment by amikacin
Patient is not expected to survive beyond 48 hours