Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients (NCT06338345) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients
France225 participantsStarted 2024-09-01
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Contraindication to the use of beta-lactam
* Administration modalities of beta-lactam not compliant with current recommendations
* Subject in exclusion period from another study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically studying how the VA-ECMO machine affects antibiotic levels in the blood, could you explain whether my current antibiotic dosing might already be a concern given that I'm on VA-ECMO?
2This study is looking at three specific antibiotics — Piperacillin-Tazobactam, Cefepime, and Meropenem — and whether patients on VA-ECMO reach effective drug concentrations; if I'm already being treated with one of these antibiotics, how are you currently monitoring whether my doses are working?
3The trial hasn't started recruiting yet, so if I might be eligible in the future, how would participating in this pharmacokinetics study affect my day-to-day care or require additional blood draws on top of what I'm already having?
4Since the goal of this trial is to find predictive factors for when antibiotic levels fall short in VA-ECMO patients, does the current evidence suggest my treatment team needs to adjust my antibiotic doses more frequently because I'm on VA-ECMO?
5Given that this is a pharmacokinetics and modeling study rather than a treatment trial, would participating only involve observation of my existing care, or could it lead to any changes in how my antibiotics are managed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 12 hour after administration
5
Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem.