Using Efferon LPS Device During and After Cardiac Surgery with Heart-Lung Machine to Reduce Multiple Organ Dysfunction Syndrome

What this Trial Is About

Researchers are evaluating the use of the Efferon LPS device for hemoadsorption during and shortly after cardiac surgery with cardiopulmonary bypass CPB. The study aims to assess whether this treatment can reduce the occurrence and severity of multiple organ dysfunction syndrome MODS, including acute kidney injury, which is a common and serious complication after cardiac surgery. The trial focuses on adults undergoing elective or emergency cardiac surgery and addresses complications linked to endotoxemia and ischemia-reperfusion injury. Participants are randomly assigned to one of two groups one receives standard cardiac surgery care with CPB without hemoadsorption, and the other receives standard care plus hemoadsorption using the Efferon LPS device. The hemoadsorption is performed twice for those in the treatment grouponce during the CPB phase of surgery for the duration of CPB, and again within 24 hours after surgery for at least 6 hours. Throughout the study, participants will be monitored for multiple outcomes including organ function assessed by the Sequential Organ Failure Assessment SOFA score over 1 to 7 days, time without vasopressors, duration of renal replacement therapy and mechanical ventilation, length of ICU stay, 28-day mortality, and incidence of postoperative complications. Assessments and safety monitoring will occur regularly during the first 28 days after surgery, helping researchers understand the impact of hemoadsorption on patient recovery and organ function.

Efferon LPS Hemoadsorption in Cardiac Surgery Patients