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The ECMOCYP (cytochromes P450 Activity) Study

ConditionsECMOCardiogenic ShockTemporary Mechanical Circulatory Support
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Geneva

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

* 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) Hospitalised in intensive care unit

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • phenotype

    Diagnostic test

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Temporary mechanical circulatory support group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the impact of temporary mechanical circulatory support 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 grou

CYP450 3A4, 2C19, 2D6, 2B6, 1A2 activity will be assessed in using the metabolic ratio of the following probe respectively: midazolam, esomeprazole, dextrometorphan, bupropion and caffein.

Time frame
During the ECMO

Secondary outcomes

1

Evaluate the correlation between the activity of CYPs and IL-6 levels

Time frame
During the ECMO
2

Evaluate the correlation between the activity of CYPs (MRs) and CRP levels

Time frame
During the ECMO
3

Evaluate the correlation between the activity of CYPs (MRs) and TNF-α levels

Time frame
During the ECMO
4

Evaluate the correlation between the activity of CYPs (MRs) and IL-1β levels

Time frame
During the ECMO

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

Jean Terrier

Collaborator

Benjamin Assouline

Collaborator

Raphël Giraud

Collaborator

Karim Bendjelid

Collaborator

Caroline Samer

Collaborator

Youssef Daali

Collaborator

Anastasia Zaslavskaya

Collaborator

Source ClinicalTrials.gov
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