Efferon LPS hemoadsorption during and after heart surgery

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Efferon JSC (industry)
• Locations: 3 sites (Barnaul and 2 other locations)
• Trial ID: NCT07532174 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Barnaul and 2 other locations

• 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

Conditions: Cardiac Disease, Multiple Organ Dysfunction Syndrome, Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption