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

Christian Schulze

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Device: CytoSorb; Other: VA-ECMO only

Study type: Interventional

Funder types: Other

Identifiers

NCT05027529

ZKSJ0131

DRKS00025265 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

42 participants in 2 patient groups, including a placebo group

VA-ECMO and CytoSorb

Experimental group

Description:

standard ICU care WITH CytoSorb

Treatment:

Device: CytoSorb

VA-ECMO only

Placebo Comparator group

Description:

standard ICU care WITHOUT CytoSorb

Treatment:

Other: VA-ECMO only