Status:
NOT_YET_RECRUITING
Pharmacokinetic Modelling of Levosimendan in Adults
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
University Hospital, Lille
Amiens University Hospital, France
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18-75 years
Brief Summary
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 ess...
Detailed Description
Cardiogenic shock is a pathological condition characterised by cardiac failure inducing tissue hypoxia and organ hypoperfusion, which can lead to multiple organ failure and death. Extracorporeal membr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06993584
Start Date
July 1 2025
End Date
August 31 2027
Last Update
June 27 2025
Active Locations (3)
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1
Cardio-Thoracic-Vascular Resuscitation Department, university Hospital of Amiens
Amiens, France, 80054
2
Anesthesia Clinic - Resuscitation, University Hospital of Lile
Lille, France, 59037
3
Anesthesia-Resuscitation Department, University Rouen Hospital
Rouen, France, 76031