Efferon LPS Hemoadsorption in Cardiac Surgery Patients
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
Efferon JSC
60 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
Summary
This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
Eligibility
Inclusion Criteria2
- Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
- EuroSCORE II ≥6%
Exclusion Criteria5
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Efferon LPS hemoadsorption will be performed twice: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07532174