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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amikacin standard dose | Active Comparator | amikacin in a single standard dose |
|
| amikacin dose for critical care patients | Active Comparator | amikacin in a single dose for critical care patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin | Drug | Amikacin administered in a single dose for critical care patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
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Inclusion Criteria:
- patients admitted at the emergency department with a diagnosis of severe sepsis or septic shock in whom amikacin is indicatied
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina De Winter, PharmD | KU Leuven - University of Leuven, University Hospitals Leuven, Department of Pharmaceutical and Pharmacological Sciences B-3000 Leuven, Belgium | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40344018 | Derived | Dia N, De Winter S, Gijsen M, Desmet S, Vanbrabant P, Peetermans W, Spriet I, Dreesen E. Dose Optimization of Amikacin in the Emergency Department: A Population Pharmacokinetics Simulation Study. Ther Drug Monit. 2025 Jun 1;47(3):353-362. doi: 10.1097/FTD.0000000000001279. Epub 2024 Dec 3. | |
| 34297338 | Derived |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| De Winter S, van Hest R, Dreesen E, Annaert P, Wauters J, Meersseman W, Van den Eede N, Desmet S, Verelst S, Vanbrabant P, Peetermans W, Spriet I. Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):653-663. doi: 10.1007/s13318-021-00698-w. Epub 2021 Jul 23. |
| 29180278 | Derived | De Winter S, Wauters J, Meersseman W, Verhaegen J, Van Wijngaerden E, Peetermans W, Annaert P, Verelst S, Spriet I. Higher versus standard amikacin single dose in emergency department patients with severe sepsis and septic shock: a randomised controlled trial. Int J Antimicrob Agents. 2018 Apr;51(4):562-570. doi: 10.1016/j.ijantimicag.2017.11.009. Epub 2017 Nov 24. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |