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NCT07532174
Efferon LPS Hemoadsorption in Cardiac Surgery Patients
Conditions: Cardiac Disease, Multiple Organ Dysfunction Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Efferon JSC
Location: Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" Barnaul
Summary
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
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
Source: ClinicalTrials.gov (NCT07532174). StuddyBuddy aggregates publicly available trial information.