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The ECMOCYP (cytochromes P450 Activity) Study

NCT06662084 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2024-10-28

No results posted yet for this study

Summary

Prospective open label observational study including patients requiring a tMCS (VA-ECMO or Impella® CP) or in in cardiogenic shock according to the SCAI (Society for Cardiovascular Angiography and Interventions) ESC (European Society of Cardiology) definition 41,42 and not requiring or not eligible to tMCS (ECMO, Impella®, intra-aortic balloon pump) (control group).

Conditions

  • ECMO
  • Cardiogenic Shock
  • Temporary Mechanical Circulatory Support

Interventions

DIAGNOSTIC_TEST

phenotype

Eligible patients will receive orally the cocktail probe drugs ( via a naso-gastric tube at D3 after tMCS implantation or after the beginning of the cardiogenic shock for the control group) and via an oral administration at 14 days after tMCS explantation (or cardiogenic shock termination for the control group defined as: no need to use inortropic or vasopressive agent and absence of organ insufficiency). The phenotyping probe drugs of the Geneva Cocktail will be given as: one capsule containing the remaining probe 'cocktail' drugs. According to clinical experience in our intensive care unit department, inflammation related to tMCS peaks at D3 after tMCS implantation. Blood samples will be collected from the central venous line 2 hours after drug administration for CYP phenotyping and genotyping. Inflammatory markers blood levels (Il-6, TNF-α, Il-1β, IFN-γ) will be measured at tMCS implantation or shock initiation and at the same time than CYP phenotyping.

Sponsors & Collaborators

  • Jean Terrier

    collaborator UNKNOWN

  • Benjamin Assouline

    collaborator UNKNOWN

  • Raphël Giraud

    collaborator UNKNOWN

  • Karim Bendjelid

    collaborator UNKNOWN

  • Caroline Samer

    collaborator UNKNOWN

  • Youssef Daali

    collaborator UNKNOWN

  • Anastasia Zaslavskaya

    collaborator UNKNOWN

  • University Hospital, Geneva

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Switzerland

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 NCT06662084 on ClinicalTrials.gov