About this trial
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 criteria
Qualifiers
Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
EuroSCORE II ≥6%
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efferon LPS