About this trial
The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.
Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.
We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing VA-ECMO
Patients requiering initiation of a novel antibiotic therapy with one of the studied beta-lactam (Piperacillin-Tazobactam, Cefepime, or Meropenem) while under VA-ECMO
With an expected survival exceeding 24 hours
Patient's or their trusted person's consent
Disqualifiers
Subject under administrative or judicial surveillance
Non-affiliation to social insurance
Pregnant or lactating patient
Antibiotic therapy of interest already initiated before VA-ECMO implantation
Trial design
Single group
Treatments tested in this trial
Therapeutic drug monitoring of beta-lactam
Diagnostic testDuring the 24 first hours after inclusion, 5 blood samples will be collected to mesure plasmatic concentrations of the studied beta-lactam, of creatinin and of albumin
Treatment groups
Trial outcomes
Primary outcomes
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.
Plasmatic concentrations during the 24 first hours following the initiation of the antibiotherapy
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.
Plasmatic concentrations during the 24 first hours following the initiation of the antibiotherapy
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.
Plasmatic concentrations during the 24 first hours following the initiation of the antibiotherapy
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.
Plasmatic concentrations during the 24 first hours following the initiation of the antibiotherapy
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: