The ECMOCYP (cytochromes P450 Activity) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Geneva
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- phenotype
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Geneva
Lead sponsor
Jean Terrier
Collaborator
Benjamin Assouline
Collaborator
Raphël Giraud
Collaborator
Karim Bendjelid
Collaborator
Caroline Samer
Collaborator
Youssef Daali
Collaborator
Anastasia Zaslavskaya
Collaborator
Source ClinicalTrials.gov