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Pharmacokinetic Modelling of Levosimendan in Adults

NCT06993584 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-27

No results posted yet for this 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.

Conditions

  • Cardiogenic Shock

Interventions

OTHER

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.

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • Amiens University Hospital, France

    collaborator UNKNOWN

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Thomas TD DUFLOT, PharmD · pharmacology department, University Hospital of Rouen

  • Emmanuel BESNIER, MD, PHD · anesthesiology, University Hospital of Rouen

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-30
Completion
2027-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993584 on ClinicalTrials.gov