Using Efferon LPS to reduce complications during heart surgery
Efficacy and Safety of Lipopolysaccharide Adsorption (Efferon LPS) During Cardiac Surgery Using Cardiopulmonary Bypass to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period
This study is testing if a new device can help reduce complications like kidney injury during heart surgery for patients who are having planned procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06659289 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of the Efferon LPS hemoperfusion device during cardiac surgeries that require cardiopulmonary bypass. The device aims to mitigate the immune response and reduce the risk of acute kidney injury (AKI) caused by endotoxemia and ischemia-reperfusion injury. By filtering out harmful toxins and inflammatory mediators, the study seeks to improve post-operative outcomes for patients undergoing heart surgery. The trial will include patients scheduled for elective cardiac procedures, excluding those with certain pre-existing conditions.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective cardiac surgeries requiring cardiopulmonary bypass.
Not a fit: Patients with emergency cardiac surgery needs or severe pre-existing conditions such as advanced chronic kidney disease or recent myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury and improve recovery outcomes for cardiac surgery patients.
How similar studies have performed: While the use of hemoperfusion devices has been explored in various contexts, this specific application during cardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass Exclusion Criteria: * Emergency nature of cardiac surgery * Cases in which a surgical procedure is required in addition to an aortocoronary artery bypass graft operation * History of aortocoronary bypass surgery * History of hemato-oncology * Receiving immunosuppressive therapy for cancer and autoimmune diseases * Sepsis, acute heart failure, acute respiratory failure, acute kidney injury at the time of enrolment * Chronic kidney disease, stage 5D (requiring continuous hemodialysis) * Treatment with renal replacement therapy in the past 90 days * Presence of cirrhosis (\>5 Child-Pugh score) * Acute pulmonary embolism * Acute myocardial infarction within 3 weeks before elective surgery * Left ventricular ejection fraction (LVEF) less than 40% according to echocardiography * Acute cerebrovascular accident within 3 weeks before elective surgery * Pregnancy * Any other clinical condition of the patient that, in the opinion of the investigator, precludes inclusion in this study
Where this trial is running
Saint Petersburg
- Pavlov First Saint Petersburg State Medical University — Saint Petersburg, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Yuri Polushin, PhD,MD — Pavlov First Saint Petersburg State Medical University
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: ais@efferon.ru
- Phone: +79636564765
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.