Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department

Universitaire Ziekenhuizen KU Leuven100 enrolled

Overview

The aim of the study is the evaluation of PK/PD target attainment of amikacin in ED patients with severe sepsis and septic shock.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Sepsis

Interventions

AmikacinDRUG

Amikacin administered in a single dose for critical care patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied Exclusion Criteria: * \< 18 years * pregnancy * burns * amikacin treatment in the previous 2 weeks * known allergy to aminoglycosides * Do Not Reanimate Code ≥ 2 * Hospitalized patients with a prolonged deep venous or arterial catheder * Continuous renal replacement, intermittent hemodialysis and death within the time of start of amikacin replacement and 1 hour later

Outcomes

Primary Outcomes

Number of participants with amikacin PK/PD target attainment

The primary outcome of this study was evaluation of PK/PD target attainment defined as amikacin peak concentration/Minimal Inhibitory Concentration \> 8 in the 15 vs.25 mg/kg amikacin group in function of 1) actual MIC of isolated pathogens 2) breakpoints of European Committe on Antimicrobial susceptibility testing (EUCAST) of Enterobacteriaceae and Pseudomonas aeruginosa

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Data from ClinicalTrials.gov

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