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

Sponsor
University Hospital, Grenoble
Study ID
NCT06338345
Status
Not Yet Recruiting

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Conditions

  • Cardiac Arrest
  • Cardiogenic Shock
  • Extracorporeal Membrane Oxygenation Complication
  • Infections
  • Post-cardiac Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

First listed
Mar 29, 2024
Start date
Sep 1, 2024
Status verified
Jan 2024
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Piperacillin Tazobactam
    75 patients under VA-ECMO receiving a novel administration of Piperacillin Tazobactam.
  • Experimental: Cefepime
    75 patients under VA-ECMO receiving a novel administration of Cefepime.
  • Experimental: Meropenem
    75 patients under VA-ECMO receiving a novel administration of Meropenem.

Primary Outcome Measure

Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. [ Time Frame: 1 hour after administration ]

Central Contacts

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