Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock
Not Applicable
Completed
- Conditions
- Shock, Septic
- Interventions
- Other: Amikacin dose optimization
- Registration Number
- NCT04178148
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BestDose Amikacin dose optimization Therapeutic drug optimization of amikacin using the BestDose software algorithm
- Primary Outcome Measures
Name Time Method Patients reaching target amikacin maximum concentration following second dose 30 minutes after second dose of amikacin Yes/no; Cmax 60-80mg/l
- Secondary Outcome Measures
Name Time Method Mortality Day 28 Patients reaching target amikacin minimum concentration following third dose 24 hours after third dose of amikacin Yes/no
Patients reaching target amikacin minimum concentration following second dose 24 hours after second dose of amikacin Yes/no
Patients reaching target amikacin maximum concentration following third dose 30 minutes after third dose of amikacin Yes/no; Cmax 60-80mg/l
Time taken to reach recommended Cmax during amikacin therapy Maximum 7 days Hours
Clinical cure test Day 7 Either clinical-evaluated or assessed according to patient medical files: classified as resolved, improved, failed
Number of days without renal replacement therapy Day 28 Number
Number of days without vasopressors Day 28 Number
Number of days without mechanical ventilation Day 28 Number
Trial Locations
- Locations (1)
CHU de Nimes
🇫🇷Nîmes, France