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

Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02365272

Enrollment

100

Registered

2015-02-18

Start date

2012-12-31

Completion date

2014-12-31

Last updated

2015-02-18

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

Conditions

Sepsis

Keywords

pharmacokinetics, aminoglycosides

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.

Interventions

DRUGAmikacin

Amikacin administered in a single dose for critical care patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026