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

Last updated: March 20, 2025
Sponsor: Christian Schulze
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Low Blood Pressure (Hypotension)

Occlusions

Treatment

CytoSorb

VA-ECMO only

Clinical Study ID

NCT05027529
ZKSJ0131
DRKS00025265
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cardiogenic shock of any cause and indication for VA-ECMO

  • Age between 18 and 80

  • Signed informed consent

Exclusion

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 Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: CytoSorb
Phase:
Study Start date:
May 21, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Jena University Hospital, Department of Cardiology

    Jena, Thuringia 07747
    Germany

    Active - Recruiting

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