Impact of VA-ECMO with CytoSorb in patients with cardiogenic shock
ECMOsorb Trial - Impact of a VA-ECMO in Combination with CytoSorb in Critically Ill Patients with Cardiogenic Shock- a Prospective, Randomized, Blinded, Monocenter Trial.
This study is testing if using a special device with a heart-lung machine can help people in severe heart failure feel better compared to just using the heart-lung machine alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 1 site (Jena, Thuringia) |
| Trial ID | NCT05027529 on ClinicalTrials.gov |
What this trial studies
The ECMOsorb study investigates the effects of combining veno-arterial extracorporeal membrane oxygenation (VA-ECMO) with an extracorporeal cytokine hemadsorption system in critically ill patients suffering from cardiogenic shock. This prospective, interventional, randomized controlled trial aims to assess hemodynamic improvements, measured by the Inotropic Score, 72 hours after initiating treatment with either the cytokine adsorber or a standard ECMO tube. The study will provide insights into the potential benefits of this combined approach in managing severe cardiac conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 experiencing cardiogenic shock requiring VA-ECMO.
Not a fit: Patients with contraindications to VA-ECMO or those with severe concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hemodynamic stability and outcomes for patients with cardiogenic shock.
How similar studies have performed: While the combination of VA-ECMO and cytokine hemadsorption is a novel approach, similar studies have shown promising results in improving outcomes in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jena, Thuringia
- Jena University Hospital, Department of Cardiology — Jena, Thuringia, Germany (Recruiting)
Study contacts
- Study coordinator: Christian Schulze, Prof.
- Email: Christian.Schulze@med.uni-jena.de
- Phone: 004936419324100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.