Evaluating cytochrome P450 activity in patients with temporary mechanical circulatory support

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

This study is testing how temporary heart support affects certain liver enzymes in patients with severe heart problems, comparing those on different devices and looking at inflammation levels.

Quick facts

• Study type: Observational
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Geneva (other)
• Locations: 1 site (Geneva)
• Trial ID: NCT06662084 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the impact of temporary mechanical circulatory support (tMCS) on cytochrome P450 (CYP) activity in patients experiencing refractory cardiogenic shock. Participants will receive the Geneva cocktail at two time points: three days after tMCS implantation and fourteen days after its removal. The study will also compare CYP activity between patients on VA-ECMO and those using the Impella® CP device, while correlating CYP activity with various inflammatory markers. A control group will include patients in cardiogenic shock who do not require tMCS.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with refractory cardiogenic shock requiring tMCS or those in cardiogenic shock not eligible for tMCS.

Not a fit: Patients who are not in cardiogenic shock or do not require temporary mechanical circulatory support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of drug metabolism in critically ill patients, leading to improved medication management.

How similar studies have performed: While studies on CYP activity in critically ill patients exist, this specific approach focusing on tMCS and its effects on CYP activity is relatively novel.

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)

Where this trial is running

Geneva

• University Hospital Of Geneva — Geneva, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Jean Terrier, Dr

Conditions: ECMO, Cardiogenic Shock, Temporary Mechanical Circulatory Support, ecmo, cardiogenic shock, TMCS, CYP450, phenotyping