Efferon LPS Hemoadsorption in Cardiac Surgery Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEfferon JSC

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

Sponsors and collaborators