NCT06662084

The ECMOCYP (cytochromes P450 Activity) Study

Impact of Temporary Mechanical Circulatory Support (tMCS) on Cytochromes P450 Activity Measured with Dried Blood Spot

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 46 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Geneva cocktail will be administered on 2 occasions at D3 after tMCS implantation (or start of the cardiogenic shock) and 14 days after tMCS explantation (or cardiogenic shock termination defined as: no need to use inortropic or vasopressive agent and absence of organ insufficiency) Primary endpoint: * Evaluate the impact of tMCS on the activity of CYPs as measured with metabolic ratios MRs (CYP activity at * D3 post tMCS implantation and 14 days after tMCS explantation vs the activity of CYPs in the control group. Secondary endpoints: * Evaluate the correlation between the activity of CYPs and IL-6 levels * Evaluate the correlation between the activity of CYPs and CRP levels * Evaluate the correlation between the activity of CYPs and TNF-α levels * Evaluate the correlation between the activity of CYPs and IL-1β levels * Evaluate the correlation between the activity of CYPs and IFN-γ levels * Compare CYP activity vs expected CYP activity based on patients' CYP genotyping * Compare CYP activity between VA-EMCO and micro-axial pump device (Impella® CP)

Conditions

• ECMO
• Cardiogenic Shock
• Temporary Mechanical Circulatory Support

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	phenotype	Eligible patients will receive orally the cocktail probe drugs ( via a naso-gastric tube at D3 after tMCS implantation or after the beginning of the cardiogenic shock for the control group) and via an oral administration at 14 days after tMCS explantation (or cardiogenic shock termination for the control group defined as: no need to use inortropic or vasopressive agent and absence of organ insufficiency). The phenotyping probe drugs of the Geneva Cocktail will be given as: one capsule containing the remaining probe 'cocktail' drugs. According to clinical experience in our intensive care unit department, inflammation related to tMCS peaks at D3 after tMCS implantation. Blood samples will be collected from the central venous line 2 hours after drug administration for CYP phenotyping and genotyping. Inflammatory markers blood levels (Il-6, TNF-α, Il-1β, IFN-γ) will be measured at tMCS implantation or shock initiation and at the same time than CYP phenotyping.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: Switzerland