Efferon LPS Hemoadsorption in Cardiac Surgery Patients

NCT07532174 | Recruiting

• 1 other identifier: efferon-lps-2024-04.1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Disease; Multiple Organ Dysfunction Syndrome

Keywords

Hemoadsorption; Hemoperfusion; Extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Vasopressor free days

  1-28 days

• Renal replacement therapy (RRT) duration

  1-28 days

• Mechanical ventilation duration

  1-28 days

• Length of stay in the intensive care unit

  1-28 days

• 28 days mortality

  1-28 days

Study Arms (2)

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.

Device: Efferon LPS

Interventions

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.

Basic therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
• EuroSCORE II ≥6%

You may not qualify if:

• 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

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (3)

Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"

Barnaul, Russia

RECRUITING

Almazov National Medical Research Centre

Saint Petersburg, Russia

RECRUITING

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuri Polushin, PhD, MD

  Pavlov First Saint Petersburg State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; ais@efferon.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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%).

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

RU (3)