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Clinical Trials in France / NCT06993584
Starting soon Observational

Pharmacokinetic Modelling of Levosimendan in Adults

NCT06993584 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Rouen
Phase
Observational
Started
2025-07-01
Last updated
2025-06-27

Condition(s) studied

Cardiogenic Shock

Investigational drug(s) / intervention(s)

Adult patients in cardiogenic shock

Adult patients in cardiogenic shock: evaluate the elimination clearance of levosimendan (LVSMD) in the group without extracorporeal membrane oxygenation (ECMO) and in the group with ECMO.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Elimination Clearance of Levosimendan (LVSMD) in Adult Patients in Cardiogenic Shock with Extracorporeal Membrane Oxygenation (ECMO) — At enrollment visit, hour 1, 2 and 6 and at hour 24, 26 and 32 after enrollment visit
    The clearance (CL) of Lévosimendan (LVSMD) will be determined by the ratio of the total dose administered to the exposure characterised by the area under the curve (AUC) over time (CL=Dose/AUC). In order to obtain an accurate estimate of the AUC, blood samples will be taken from a catheter already in place for the patient's therapeutic needs and will be taken at 0, 2, 6, 24, 26 and 32 hours after the start of an intravenous infusion of LVSMD at the dosage defined according to the recommendations in the Summary of Product Characteristics (SmPC).

Trial sites (3)

FacilityCityRegionStatus
Cardio-Thoracic-Vascular Resuscitation Department, university Hospital of Amiens Amiens France
Anesthesia Clinic - Resuscitation, University Hospital of Lile Lille France
Anesthesia-Resuscitation Department, University Rouen Hospital Rouen France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06993584 on ClinicalTrials.gov ↗ ← All trials in France