Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study (AMIDIAL-ICU)

June 15, 2022 updated by: CHU de Reims
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to describe strategies of prescription and monitoring of Amikacin in intensive care patients on renal replacement therapy.

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France
        • Damien JOLLY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intensive care patients on renal replacement therapy with Amikacin treatment

Description

inclusion criteria :

  • patients in intensive care
  • patients on extrarenal replacement
  • patients with Amikacin treatment
  • patients accepting to participate in the study

exclusion criteria :

  • patients less than 18 years old
  • pregnant women
  • patients with Amikacin treatment in the previous 7 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
"Amikacin treatment" group
Intensive care patients on renal replacement therapy with Amikacin treatment
Other: Data record
Data record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of maximum concentration observed
Time Frame: Day 0
Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

February 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PO20032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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