Skip to main content
OpenTrials
Completed

NCT Number: NCT03683511

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. amikacin infusion

    Time frame: 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 outcomes

  1. maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Registry information

Official study title

Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram

Acronym: PIC-AMI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2018
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.