NCT06338345Not yet recruiting
Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients
Pharmacokinetics and Modelling of Beta-Lactam in Patients Undergoing Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO)
Source: ClinicalTrials.gov · Last updated 29 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 21 Mar 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University Hospital, Grenoble
- NCT number
- NCT06338345
What you commit to
- Study type: Interventional
- Planned participants: 225
- From 1 Sept 2024 to the primary completion date, 1 Sept 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic therapy of interest already initiated before VA-ECMO implantation
Other
- Subject under administrative or judicial surveillance
- Non-affiliation to social insurance
- Pregnant or lactating patient
- Contraindication to the use of beta-lactam
- Administration modalities of beta-lactam not compliant with current recommendations
- Subject in exclusion period from another study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Clermont-Ferrand Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| APHP Pitié Salpétrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rouen Hopital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hôpital Rangueil, CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.