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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02898961

LOCAL/2015/JYL-01

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

The study population

Experimental group

Description:

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

Treatment:

Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin