Evaluating methods to remove inflammatory mediators in critically ill patients
Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation in Patient With Multiple Organ Dysfunction Syndrome After Heart and Aortic Surgery
This study is testing whether a special treatment that removes inflammation from the blood can help critically ill patients recover better after heart and aorta surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Petrovsky National Research Centre of Surgery Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05182723 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness and safety of extracorporeal methods designed to remove mediators of systemic inflammation in patients suffering from multiple organ dysfunction syndrome following heart and aorta surgery. Participants will be randomly assigned to receive either a hemoperfusion cartridge for cytokine sorption combined with an oXiris membrane or just the oXiris membrane. The study aims to determine which method is more effective in improving patient outcomes by reducing inflammation. All patients will provide informed consent before participation.
Who should consider this trial
Good fit: Ideal candidates are patients with multiple organ dysfunction syndrome after heart and aorta surgery who meet specific inflammatory markers.
Not a fit: Patients who cannot receive heparin due to bleeding risks or heparin-induced thrombocytopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with severe systemic inflammation after major surgeries.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in managing systemic inflammation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * multiple organ dysfunction; * SOFA equal to or more than 4; * CRP equal to or more than 100 ng / ml; * increase of IL6 by 5 times or more Exclusion Criteria: * the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
Where this trial is running
Moscow
- Petrovsky Nacional research Centre of Surgery — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Tatiana Marchenko — Petrovsky National Research Centre of Surgery
- Study coordinator: Aleksandr Eremenko, MD
- Email: aeremenko54@mail.ru
- Phone: +79037129303
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.