Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Therapeutic drug monitoring of beta-lactam

    Diagnostic test

    During 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

225 Participants
are divided into 3 treatment groups
Group A: Piperacillin TazobactamExperimental treatment 1 intervention
Group B: CefepimeExperimental treatment 1 intervention
Group C: MeropenemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 hour after administration
2

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

Time frame
3 hour after administration
3

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

Time frame
6 hour after administration
4

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

Time frame
12 hour after administration

Secondary outcomes

Other outcomes

Sponsors and contacts

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