Cardiac Disease, Multiple Organ Dysfunction Syndrome
Conditions
Keywords
Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
Brief 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.
Detailed description
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.
Interventions
DEVICEEfferon 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.
Sponsors
Efferon JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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%).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA | 1-7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor free days | 1-28 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. |
| Renal replacement therapy (RRT) duration | 1-28 days | * 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. |
| Mechanical ventilation duration | 1-28 days | 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. |
| Length of stay in the intensive care unit | 1-28 days | Time (number of days) from surgery to transfer from the intensive care unit within 60 days |
| 28 days mortality | 1-28 days | Mortality rate |
| Incidence of postoperative complications | 1-28 days | 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. |
Countries
Russia
Contacts
CONTACTAlexandr Shelehov-Kravchenko, PhD, MD
PRINCIPAL_INVESTIGATORYuri Polushin, PhD, MD
Pavlov First Saint Petersburg State Medical University
Outcome results
None listed