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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Switzerland
University Hospital Of Geneva
RECRUITING
Geneva
Contact Information
Primary
Jean Terrier, Dr
jean.terrier@hug.ch
+41795530888
Backup
Anastasia Zaslavskaya, Dr
anastasia.zaslavskaya@hug.ch
+41795535729
Time Frame
Start Date: 2024-10
Estimated Completion Date: 2026-07
Participants
Target number of participants: 46
Treatments
Temporary mechanical circulatory support group
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).
Control group
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)
Related Therapeutic Areas
Sponsors
Collaborators: Anastasia Zaslavskaya, Karim Bendjelid, Caroline Samer, Raphël Giraud, Jean Terrier, Youssef Daali, Benjamin Assouline
Leads: University Hospital, Geneva

This content was sourced from clinicaltrials.gov