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

Launched by CHRISTIAN SCHULZE · Aug 24, 2021

Keywords

ClinConnect Summary

The ECMOsorb Trial is studying a new treatment approach for patients who are critically ill and experiencing cardiogenic shock, which is a severe condition where the heart cannot pump enough blood. This trial is looking at the effects of a special heart-support device called veno-arterial ECMO, combined with a system that helps remove harmful substances from the blood. The goal is to see if this combination can improve outcomes for patients in this serious condition.

To join the trial, participants need to be between 18 and 80 years old and diagnosed with cardiogenic shock that requires ECMO treatment. They must also be able to give their consent to participate. However, some individuals will not be eligible, such as those who are pregnant, have certain infections, or have other serious health issues. Participants in the trial can expect close monitoring and care from medical professionals throughout the study, as researchers gather important information about the safety and effectiveness of this treatment approach.

Gender

ALL

Eligibility criteria

• 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