Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model

Completed

• Conditions: Pharmacokinetics

• Registration Number: NCT03683511
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04-21
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-21
• Last Update Submitted: 2018-09-21
• Study First Posted: 2018-09-25
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
amikacin infusion	one hour after beginning of infusion.ed	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.

Secondary Outcome Measures

Name	Time	Method
maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.	24 hours after beginning of infusion	Target is 2.5 mg/L. Those PTA will be calculated using the final pharmacokinetics model, according to the dependent variables.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France