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NCT02898961 Clinical Trial

Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

Sepsis Clinical Trial

— Aminoside_II  

Official title:
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02898961
Other study ID # LOCAL/2015/JYL-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2014
Est. completion date February 2015

Study information
Verified date December 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICU patient with severe sepsis - Treated with aminoglycosides Exclusion Criteria: - Renal replacement therapy - Allergy to aminoglycosides - Confirmed and/or suspected to have myasthenia - ICU-acquired neuromuscular disorder - Under guardianship - Prisoners - The patient has already participated in the present protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 30 mg/kg amikacin or 8 mg/kg gentamicin
In order to improve the achievement of target peak concentrations, either 30 mg/kg amikacin or 8 mg/kg gentamicin was prescribed in ICU patients with severe sepsis. In combination with broad-spectrum antibiotics, according to the suspected pathogens and local clinical practice, 30 mg/kg amikacin or 8 mg/kg gentamicin was given (30 min intravenous infusion; the dosage ampoule was systematically emptied with a 5 ml flush). The peak serum concentration sampling occurred 30 minutes after the end of the infusion.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

References & Publications (1)

Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Presence/absence of target peak serum concentration of aminosides Achievement of targeted peak serum concentration? 30 minutes after the end of the infusion.
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