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ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock

ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock

Recruiting
18-80 years
All
Phase N/A

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Overview

In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined

Description

The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.

Eligibility

Inclusion Criteria:

  • Cardiogenic shock of any cause and indication for VA-ECMO
  • Age between 18 and 80
  • Signed informed consent

Exclusion Criteria:

  • Current participation in another interventional trial
  • Pregnancy
  • Current immunosuppressive or immunomodulatory therapy
  • Contraindications to VA-ECMO implantation.
  • Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
  • Shock duration> 12 h before evaluation.
  • Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
  • Aortic valve insufficiency / stenosis at least II °.
  • Age > 80 years.
  • CNS disease with fixed, dilated pupils (not drug-induced).
  • Severe concomitant disease with limited life expectancy <6 months.
  • CPR> 60min.
  • Shock due to other reasons
  • HIT positive (Heparin induced thrombocytopenia)
  • Very low platelet counts (< 20,000/µl)
  • Body weight less than 45 kg

Study details
    Cardiogenic Shock

NCT05027529

Christian Schulze

27 January 2024

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