An interventional study of Efferon LPS in Cardiac Disease and Multiple Organ Dysfunction Syndrome, sponsored by Efferon JSC. Recruiting at 3 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Efferon JSC · Not applicable, Interventional, and Treatment
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.
Annually, over 1 million people worldwide undergo cardiac surgery. Most cardiac procedures still require cardiopulmonary bypass (CPB), myocardial protection during aortic cross-clamping, and the induction of cardioplegic arrest by administering cardioplegic solutions into the coronary circulation. All of these factors contribute to ischemia-reperfusion injury of the myocardium, which remains a leading cause of acute heart failure following the restoration of spontaneous circulation and, consequently, the development of post-perfusion multiple organ dysfunction, particularly acute kidney injury (AKI).
AKI occurs in approximately 7% of all hospitalized patients, 30% of intensive care unit patients, and up to 30% of patients undergoing cardiac surgery. Endotoxemia is one of the major contributors to the development of AKI. Septic AKI, compared with non-septic AKI, is associated with poorer prognosis, longer hospital stays, and lower survival rates.
The goal of the study is to evaluate the safety and efficacy 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.
Exclusion Criteria:
Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoadsorption.
Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoadsorption with Efferon LPS.
Device: Efferon LPS
Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Efferon LPS hemoadsorption will be performed twice: 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.
SOFA
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
Time frame: 1-7 days
Vasopressor free days
* Vasopressor free days = 0 if subject dies within 28 days of starting vasopressor support. * Vasopressor free days = 28 - x if vasopressor support is successfully discontinued x days after initiation. * Vasopressor free days = 0 if the subject requires vasopressor support for more than 28 days.
Time frame: 1-28 days
Renal replacement therapy (RRT) duration
* RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. * RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. * RRT-free days = 0 if the subject requires RRT for more than 28 days.
Time frame: 1-28 days
Mechanical ventilation duration
Ventilator-free days = 0 if subject dies within 28 days of mechanical ventilation. Ventilator-free days = 28 - x if successfully liberated from ventilation x days after initiation. Ventilator-free days = 0 if the subject is mechanically ventilated for \>28 days.
Time frame: 1-28 days
Length of stay in the intensive care unit
Time (number of days) from surgery to transfer from the intensive care unit within 60 days
Time frame: 1-28 days
28 days mortality
Mortality rate
Time frame: 1-28 days
Incidence of postoperative complications
Incidence of postoperative complications, including sepsis, pneumonia, surgical site infections, stroke, bleeding events, and the need for mechanical ventilation, renal replacement therapy, and vasopressor support.
Time frame: 1-28 days
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Efferon JSC