Efferon LPS Hemoadsorption in Cardiac Surgery Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease; Multiple Organ Dysfunction Syndrome
• Intervention / Treatment: Device: Efferon LPS

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandr Shelehov-Kravchenko, PhD, MD; Phone Number: +79636564765; Email: ais@efferon.ru

Study Locations

• Russia
  • Barnaul, Russia
    • Recruiting
    • Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
    • Contact: Alexander Efremushkin, PhD, MD; Email: zavoar1@akkd.ru
  • Saint Petersburg, Russia
    • Recruiting
    • Almazov National Medical Research Centre
    • Contact: Andrey Bautin, PhD, MD; Email: bautin_ae@almazovcentre.ru
  • Saint Petersburg, Russia
    • Recruiting
    • Pavlov First Saint Petersburg State Medical University
    • Contact: Yuri Polushin, PhD, MD; Email: polushin1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline therapy; Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoadsorption.
Experimental: Basic therapy + Efferon LPS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-28 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.	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

Collaborators and Investigators

• Sponsor: Efferon JSC
• Investigators: Principal Investigator: Yuri Polushin, PhD, MD, Pavlov First Saint Petersburg State Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemoperfusion; Hemoadsorption; LPS adsorption; Extracorporeal therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Shock; Pathological Conditions, Signs and Symptoms; Heart Diseases; Multiple Organ Failure
• Other Study ID Numbers: efferon-lps-2024-04.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No