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

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin

• Registration Number: NCT02898961
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The study population	30 mg/kg amikacin or 8 mg/kg gentamicin	ICU patients with severe sepsis treated with aminoglycosides were recruited. Intervention: 30 mg/kg amikacin or 8 mg/kg gentamicin

Primary Outcome Measures

Name	Time	Method
Presence/absence of target peak serum concentration of aminosides	30 minutes after the end of the infusion.	Achievement of targeted peak serum concentration?