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

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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

Tracking Information
First Submitted Date March 24, 2020
First Posted Date March 26, 2020
Last Update Posted Date June 11, 2020
Actual Study Start Date May 25, 2020
Estimated Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2020)
Measurement of maximum concentration observed [ Time Frame: Day 0 ]
Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
Official Title Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Intensive care patients on renal replacement therapy with Amikacin treatment
Condition Amikacin Treatment
Intervention Other: Data record
Data record
Study Groups/Cohorts "Amikacin treatment" group
Intensive care patients on renal replacement therapy with Amikacin treatment
Intervention: Other: Data record
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 24, 2020)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 25, 2021
Estimated Primary Completion Date February 25, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Vincent DUPONT 0326788819 vdupont@chu-reims.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04322019
Other Study ID Numbers PO20032
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date June 2020