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Pharmacokinetic Modelling of Levosimendan in Adults
Sponsor: University Hospital, Rouen
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.
Official title: Pharmacokinetic Modelling of Levosimendan in Adults in Cardiogenic Shock With or Without Extracorporeal Membrane Oxygenation Support
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-07-01
Completion Date
2027-08-31
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
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