Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients
- Conditions
- Antibiotic ToxicitySepsisSeptic ShockCritical Illness
- Interventions
- Other: dosage of concentration of piperacillin and cefepim
- Registration Number
- NCT04530045
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.
Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.
For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- Minimun age limits 18 years
- Critically ill patient receiving piperacillin or cefepim administered continuously
- Beta lactam allergy
- Pregnancy
- Age less than 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description critically ill patients dosage of concentration of piperacillin and cefepim Critically ill patients receiving continuous infusion of piperacillin/tazbactam or cefepim and dosage of plasma concentration of the B lactam administered
- Primary Outcome Measures
Name Time Method to determine the percentage of patients who met the PK/PD targets at 24 hours Day 1 PK/PD target was defined as follows:
Concentration of piperacillin or cefepim between a lower and a upper limit:
* The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria
* The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively
Consequently :
* for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l
* for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l
- Secondary Outcome Measures
Name Time Method to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours Day 1 PK/PD target "exposure" take into account only the the lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria
Consequently :
* for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is above 32 mg/l
* for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is above 4 mg/lfactors associated with target attainment at day 1 Statistical analysis after 2 years of inclusion effect of presence of septic shock on antibiotic concentration
factors associated with dose changing Statistical analysis after 2 years of inclusion effect of renal clearance on number of dose changing after analyse of antibiotic concentration
Trial Locations
- Locations (2)
Emmanuel NOVY
🇫🇷Vandoeuvre Les Nancy, Lorraine, France
Central Hospital
🇫🇷Vandoeuvre les Nancy, France