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

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Drug: Amikacin

• Registration Number: NCT02365272
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-01-27
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-10
• Last Update Submitted: 2015-02-10
• Study First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amikacin standard dose	Amikacin	amikacin in a single standard dose
amikacin dose for critical care patients	Amikacin	amikacin in a single dose for critical care patients

Primary Outcome Measures

Name	Time	Method
Number of participants with amikacin PK/PD target attainment	Participants will be followed for the duration of hospital stay, an expected average of 5 weeks	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