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

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amikacin

Drug

Amikacin administered in a single dose for critical care patients

Primary outcomes

Number of participants with amikacin PK/PD target attainment

Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 18, 2015
Registry last updated: Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed