Pharmacokinetic/Pharmacodynamic Evaluation Amikacin in Critically Ill Patients Admitted at the Emergency Department
- 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
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
- Secondary Outcome Measures
Name Time Method