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

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

3
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" Barnaul Russia
Almazov National Medical Research Centre Saint Petersburg Russia
Pavlov First Saint Petersburg State Medical University Saint Petersburg Russia

Sponsors and collaborators

Efferon JSC

Lead sponsor