ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With… (NCT05027529) | Clinical Trial Compass
CompletedNot Applicable
ECMOsorb Trial - Impact of a VA-ECMO in Combination With CytoSorb in Critically Ill Patients With Cardiogenic Shock
Germany42 participantsStarted 2021-05-21
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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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
What they're measuring
1
Change in inotropic score after 72h (difference between the two study groups)