The ECMOCYP (cytochromes P450 Activity) Study

Launched by UNIVERSITY HOSPITAL, GENEVA · Oct 25, 2024

Keywords

ClinConnect Summary

The ECMOCYP Study is a clinical trial that aims to understand how certain medications affect patients who are experiencing severe heart problems, known as cardiogenic shock, and who may need temporary mechanical support to help their hearts pump blood. Specifically, the study focuses on patients using devices like VA-ECMO or Impella® CP, which assist in circulating blood when the heart is struggling. There is also a control group of patients who are in similar situations but do not require these devices.

To participate, individuals must be over 18 years old and able to understand French. They should have severe heart failure that requires temporary support or meet specific criteria for being in cardiogenic shock without needing mechanical support. Participants can expect to provide consent through a representative, as they may be sedated during the initial process. This study is currently recruiting participants, and it’s important to note that those with certain conditions, like severe kidney or liver issues, or who are taking specific medications that affect drug metabolism, will not be eligible for the trial.

Gender

ALL

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)