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

  • STATUS
    Recruiting
  • End date
    Jun 6, 2023
  • participants needed
    54
  • sponsor
    Christian Schulze
Updated on 6 September 2021

Summary

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.

Details
Condition Cardiogenic shock
Treatment CytoSorb, VA-ECMO only
Clinical Study IdentifierNCT05027529
SponsorChristian Schulze
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

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/l)
Body weight less than 45 kg
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