Actively Recruiting

Age: 18Years +
All Genders
NCT06662084

The ECMOCYP (cytochromes P450 Activity) Study

Led by University Hospital, Geneva · Updated on 2024-10-28

46

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Geneva

Lead Sponsor

J

Jean Terrier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The ECMOCYP (cytochromes P450 Activity) Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients with refractory cardiogenic shock requiring temporary mechanical circulatory support (VA-ECMO or Impella42 CP)
  • Male and female patients in cardiogenic shock per SCAI and ESC definitions not requiring or not eligible for temporary mechanical circulatory support (control group)
  • Age over 18 years old
  • Able to understand French
  • Able to give consent or consent provided by therapeutic representative or relatives if sedated and intubated; patient consent sought at second blood sample after tMCS removal
Not Eligible

You will not qualify if you...

  • Patients with refractory ARDS requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)
  • Unable to receive the Geneva cocktail by enteral route
  • Severe or terminal renal impairment (GFR < 30 ml/min by Cockroft-Gault)
  • Severe chronic hepatic insufficiency (CHILD B-C)
  • Sensitivity to any drug in the Geneva cocktail
  • Use of drugs strongly altering CYP activity (strong inhibitors or inducers)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Of Geneva

Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

J

Jean Terrier, Dr

CONTACT

A

Anastasia Zaslavskaya, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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The ECMOCYP (cytochromes P450 Activity) Study | DecenTrialz