Shock, Septic
Conditions
Keywords
Pharmacokinetics, dose optimisation, aminoglycosides
Brief summary
Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.
Interventions
OTHERAmikacin dose optimization
Therapeutic drug optimization of amikacin using the BestDose software algorithm
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient or their legal representative must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient has septic shock according to the SEPSIS-3 definition in the 24 hours preceding inclusion, regardless of the source of infection * Patient having already received a first dose of amikacin in the 22 preceding hours * Patient with an expectation of receiving at least 2 doses of amikacin * Patient with available amikacin therapeutic drug monitoring
Exclusion criteria
* The subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study * The patient is pregnant, parturient or breastfeeding * Patient has a contra-indication or an allergy to treatment by amikacin * Patient is not expected to survive beyond 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients reaching target amikacin maximum concentration following second dose | 30 minutes after second dose of amikacin | Yes/no; Cmax 60-80mg/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days without renal replacement therapy | Day 28 | Number |
| Patients reaching target amikacin minimum concentration following third dose | 24 hours after third dose of amikacin | Yes/no |
| Time taken to reach recommended Cmax during amikacin therapy | Maximum 7 days | Hours |
| Patients reaching target amikacin minimum concentration following second dose | 24 hours after second dose of amikacin | Yes/no |
| Clinical cure test | At end of treatment (Maximum day 7) | Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed |
| Number of days without vasopressors | Day 28 | Number |
| Number of days without mechanical ventilation | Day 28 | Number |
| Mortality | Day 28 | — |
| Patients reaching target amikacin maximum concentration following third dose | 30 minutes after third dose of amikacin | Yes/no; Cmax 60-80mg/l |
Countries
France
Outcome results
None listed