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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322019
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
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.

Condition or disease Intervention/treatment
Amikacin Treatment Other: Data record

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.

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : February 25, 2021
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Measurement of maximum concentration observed [ Time Frame: Day 0 ]
    Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive care patients on renal replacement therapy with Amikacin treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322019


Contacts
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Contact: Vincent DUPONT 0326788819 vdupont@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Vincent DUPONT    0326788819 ext 0033    vdupont@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04322019    
Other Study ID Numbers: PO20032
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Amikacin
intensive care
renal replacement therapy
prescription strategy,
monitoring strategy