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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02898961
Acronym
Aminoside_II
Enrollment
63
Registered
2016-09-13
Start date
2014-10-01
Completion date
2016-12-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

DRUG30 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence/absence of target peak serum concentration of aminosides30 minutes after the end of the infusion.Achievement of targeted peak serum concentration?

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026