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The ECMOCYP (cytochromes P450 Activity) Study
RECRUITINGSponsored by University Hospital, Geneva
Actively Recruiting
SponsorUniversity Hospital, Geneva
Started2024-10
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06662084
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).
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Male and female patients presenting a refractory cardiogenic shock, requiring temporary mechanical circulatory support (tMCS), with either the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or a micro-axial pump device (Impella® CP). * Male and female patients in cardiogenic shock according to the SCAI (Society for Cardiovascular Angiography and Interventions) ESC (European Society of Cardiology) definition and not requiring or not eligible to temporary mechanical circulatory support (tMCS). (e.g. ECMO, Impella®, intra-aortic balloon pump) (control group) * Age \> 18 years old * Comprehension of French * Ability to give consent (consent will be sought from the therapeutic representative or from relatives as the patient will be sedated and intubated. Definitive consent will be sought at patient's second blood sample planned after tMCS explantation (in case of patient's favorable outcome). Exclusion Criteria: * Male and female patients presenting a refractory ARDS requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO) * Inability to receive the Geneva cocktail by enteral way * Severe or terminal Renal impairment (defined as GFR\<30ml/min according to Cockroft-Gault) * Severe chronic hepatic insufficiency (CHILD B-C) * Sensitivity to any of the drugs used in the Geneva Cocktail * Intake of drugs altering CYPs activity (Strong inhibitor or inducer based on https://www.hug.ch/sites/hde/files/structures/pharmacologie\_et\_toxicologie\_cliniques/a5\_cytochromes\_6\_2.pdf)
Conditions4
Cardiogenic ShockECMOHeart DiseaseTemporary Mechanical Circulatory Support
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Actively Recruiting
SponsorUniversity Hospital, Geneva
Started2024-10
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06662084