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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline therapy | No Intervention | Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoadsorption. | |
| Basic therapy + Efferon LPS | Experimental | Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoadsorption with Efferon LPS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efferon LPS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor free days |
| 1-28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandr Shelehov-Kravchenko, PhD, MD | Contact | +79636564765 | ais@efferon.ru |
| Name | Affiliation | Role |
|---|---|---|
| Yuri Polushin, PhD, MD | Pavlov First Saint Petersburg State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" | Recruiting | Barnaul | Russia |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomized in a 1:1 ratio using stratified randomization based on preoperative risk assessed by EuroSCORE II, with two strata: high risk (EuroSCORE II 6-10%) and very high risk (>10%).
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| Renal replacement therapy (RRT) duration |
|
| 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. | 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 | 1-28 days |
| 28 days mortality | Mortality rate | 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. | 1-28 days |
| Almazov National Medical Research Centre | Recruiting | Saint Petersburg | Russia |
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| Pavlov First Saint Petersburg State Medical University | Recruiting | Saint Petersburg | Russia |
|