Efferon LPS hemoadsorption during and after heart surgery
Official title: Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period
Run by Efferon JSC · NCT07532174 · Data updated 2026-11-12
This trial tests whether using the Efferon® LPS filter during cardiopulmonary bypass and again within 24 hours afterward can lower the chance and severity of multiple organ dysfunction in adults having cardiac surgery who are at higher surgical risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 3 sites (Barnaul and 2 other locations) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07532174 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults having elective or emergency cardiac surgery with cardiopulmonary bypass who have a EuroSCORE II of 6% or higher and who do not meet exclusion criteria are the intended candidates.
✕Probably not a fit
Patients with procalcitonin ≥2 ng/mL, dialysis-dependent kidney failure, Child-Pugh class C liver disease, or on ongoing immunosuppressive therapy are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial enrolling adults undergoing elective or emergency cardiac surgery with cardiopulmonary bypass and a EuroSCORE II ≥6%. Participants randomized to the intervention receive two hemoadsorption sessions with the Efferon® LPS device: one during CPB for the duration of bypass and a second session within 24 hours postoperatively for at least six hours. Key exclusions include high procalcitonin, dialysis-dependent chronic kidney disease, severe liver failure, and ongoing immunosuppression. The main goal is to see if intraoperative plus early postoperative LPS adsorption reduces the incidence and severity of postoperative multiple organ dysfunction syndrome, including acute kidney injury.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative multiple organ dysfunction and acute kidney injury after cardiopulmonary bypass, potentially shortening ICU stays and improving recovery.
How similar studies have gone: Smaller trials and observational studies of hemoadsorption in sepsis and perioperative settings have shown reductions in inflammatory markers and mixed clinical signals, but large definitive trials demonstrating clear clinical benefit are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB). * EuroSCORE II ≥6% Exclusion Criteria: * Procalcitonin ≥2 ng/mL * Severe chronic liver disease, defined as Child-Pugh class C (\>10 points) or clinically manifest hepatic failure * Dialysis-dependent chronic kidney disease (CKD) * Ongoing immunosuppressive therapy, including corticosteroids or cytotoxic agents, excluding standard perioperative medications * Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study
Where it's running
-
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
Barnaul, Russia Recruiting -
Almazov National Medical Research Centre
Saint Petersburg, Russia Recruiting -
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.