NCT06993584Not yet recruiting
Pharmacokinetic Modelling of Levosimendan in Adults
Pharmacokinetic Modelling of Levosimendan in Adults in Cardiogenic Shock With or Without Extracorporeal Membrane Oxygenation Support
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the light of current knowledge of the PK of levosimendan and its use in ECMO weaning, deciphering the mechanisms of inter-individual variability in exposure and response to levosimendan appears essential in order to better stratify patients eligible or not for this therapy and to adapt the treatment of patients in cardiogenic shock, with or without ECMO support, accordingly. The aim of this project is to use an innovative pharmacokinetic modelling approach based on clinico-biological data to study the key factors that could contribute to treatment failure in cardiogenic shock and to integrate them quantitatively for dose individualisation. The aim of this project is to conduct a prospective, multicentre, observational, comparative analysis, with minimal risks and constraints, to determine the concentrations of levosimendan and its metabolites during patient management in order to develop a pharmacokinetic model.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- University Hospital, Rouen
- NCT number
- NCT06993584
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 30 Jul 2027
- 3 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.
Other
- Pregnant, childbearing, or breastfeeding women,
- Persons deprived of their liberty by an administrative or judicial decision, or persons placed under judicial protection/guardianship or curatorship.
Who the study is looking for
- Patient between 18 and 75 years of age admitted to an intensive care unit,
- Weight ≥ 50 kg,
- Patient with cardiogenic shock defined by a SCAI stage C, D, or E score.
- The medical team plans to initiate LVSMD treatment as part of the management of cardiogenic shock, according to the recommendations in the Summary of Product Characteristics (SmPC),
- Expected life expectancy \> 48 hours,
- Patient affiliated with a social security scheme,
- Due to the life-threatening nature of cardiogenic shock, the patient or, where applicable, family members or trusted person are informed as soon as possible and their consent is requested for the possible continuation of this research. They may also object to the use of the patient's data (and blood samples) for this research.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardio-Thoracic-Vascular Resuscitation Department, university Hospital of Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Anesthesia Clinic - Resuscitation, University Hospital of Lile Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Anesthesia-Resuscitation Department, University Rouen Hospital Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.