NCT06662084 The ECMOCYP (cytochromes P450 Activity) Study
| NCT ID | NCT06662084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | ECMO |
| Study Type | OBSERVATIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-10 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 46 participants in total. It began in 2024-10 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06662084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ECMO. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06662084 currently recruiting?
Yes, NCT06662084 is actively recruiting participants. Contact the research team at jean.terrier@hug.ch for enrollment information.
Where is the NCT06662084 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT06662084 clinical trial?
NCT06662084 is sponsored by University Hospital, Geneva. The trial plans to enroll 46 participants.