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NCT Number: NCT07532174

Efferon LPS Hemoadsorption in Cardiac Surgery Patients

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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases Multiple Organ Dysfunction Syndrome Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary", Barnaul, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. SOFA

    Time frame: 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 outcomes

  1. Vasopressor free days

    Time frame: 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.

  2. Renal replacement therapy (RRT) duration

    Time frame: 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.

  3. Mechanical ventilation duration

    Time frame: 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.

  4. Length of stay in the intensive care unit

    Time frame: 1-28 days

    Time (number of days) from surgery to transfer from the intensive care unit within 60 days

  5. 28 days mortality

    Time frame: 1-28 days

    Mortality rate

  6. Incidence of postoperative complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

[email protected]

+79636564765

Sponsors and collaborators

Lead sponsor

Efferon JSC

Industry

Registry information

Official study title

Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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