Study of Temporary Mechanical Circulatory Support Effects on Cytochromes P450 Activity Using Dried Blood Samples

What this Trial Is About

This research aims to evaluate the impact of temporary mechanical circulatory support tMCS devices, such as veno-arterial extracorporeal membrane oxygenation VA-ECMO and the Impella4 CP micro-axial pump, on the activity of cytochrome P450 enzymes CYPs in patients with cardiogenic shock. The study includes patients requiring tMCS support as well as those in cardiogenic shock who are not eligible for or do not require such support, serving as a control group. The study also explores how inflammation markers relate to CYP activity and compares enzyme activity between different device types. Participants receive the Geneva cocktail orally on two occasions three days after tMCS implantation or shock onset, and 14 days after tMCS removal or resolution of cardiogenic shock. The cocktail probes CYP activity, and blood samples are collected two hours post-administration for phenotyping and genotyping. Inflammatory markers such as IL-6, TNF-b1, IL-1b2, and IFN-b3 are measured at the start of tMCS or shock and during CYP phenotyping. This observational study does not involve experimental treatments but monitors enzyme activity changes associated with mechanical support. During the study, participants undergo blood sampling for CYP phenotyping, genotyping, and inflammatory markers at specified time points. The primary outcome measures CYP activity changes between day 3 post-tMCS implantation and 14 days after device removal in comparison to controls. Secondary outcomes include correlations between CYP activity and various inflammatory markers, genotyping comparisons, and differences between VA-ECMO and Impella4 CP devices. Participants are followed until 14 days post-tMCS explantation or cardiogenic shock resolution, with all procedures conducted under clinical supervision.

The ECMOCYP (cytochromes P450 Activity) Study