Efferon LPS Hemoadsorption in Cardiac Surgery Patients
Recruiting · NCT07532174 · Interventional (participants receive a specific treatment) · Lead sponsor: Efferon JSC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
- EuroSCORE II ≥6%
Exclusion criteria
- 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
Where it is running
3 locations listed.
- 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