Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass

NCT06659289 | Terminated

• 1 other identifier: efferon-lps-2024-03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

More than 1 million people undergo cardiac surgery each year worldwide. Cardiac surgeries still in most cases require cardiopulmonary bypass, use of myocardial protection against aortic clamping and creation of cardioplegic arrest of the heart by injecting cardioplegic solutions into the coronary bed. All of the above is a source of myocardial ischemia-reperfusion injury, which remains the leading cause of acute heart failure in the period after the return of spontaneous circulation and, as a consequence, the development of post-perfusion multiple organ dysfunction syndrome and, in particular, acute kidney injury (AKI). Acute kidney injury typically develops in 7% of all hospitalised patients, 30% of intensive care unit patients and 30% of cardiac surgery patients. Endotoxemia is a major cause of AKI. Septic AKI (compared to non-septic AKI) is associated with a worse prognosis, longer hospital stay and poorer survival. The use of the Efferon LPS hemoperfusion device, which has proven efficacy in removing not only endotoxin but also cytokines, may be promising in preventing the development of multiple organ dysfunction syndrome and in particular AKI in patients after cardiac surgery with cardiopulmonary bypass.

Conditions

Cardiac Disease; Multiple Organ Dysfunction Syndrome

Keywords

Hemoperfusion; Extracorporeal therapy; Lipopolysaccharide adsorption

Outcome Measures

Primary Outcomes (1)

• Effect of the hemoperfusion with Efferon LPS device during cardiopulmonary bypass on measures of organ dysfunction

  Measured every 24 hours ± 1 hour from the end of cardiopulmonary bypass to 72 hours. The SOFA (Sequential Organ Failure Assessment) index 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 index, 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 index, the less pronounced organ failure and the better the patient's survival prognosis.

  0-72 hours

Secondary Outcomes (12)

• Incidence of post-operative acute kidney injury

  0-72 hours

• Renal function

  0-72 hours

• Duration of renal replacement therapy

  1-28 days

• Mean arterial pressure

  0-72 hours

• Duration of vasopressor support

  0-72 hours

Study Arms (2)

Baseline therapy

NO INTERVENTION

Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoperfusion.

Basic therapy + Efferon LPS

EXPERIMENTAL

Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoperfusion 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. The hemoperfusion procedure is performed at the time of cardiopulmonary bypass during cardiac surgery. The therapy (Efferon LPS hemoperfusion) is performed once. The duration of the procedure is limited by the time ofcardiopulmonary bypass.

Basic therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass

You may not qualify if:

• Emergency nature of cardiac surgery
• Cases in which a surgical procedure is required in addition to an aortocoronary artery bypass graft operation
• History of aortocoronary bypass surgery
• History of hemato-oncology
• Receiving immunosuppressive therapy for cancer and autoimmune diseases
• Sepsis, acute heart failure, acute respiratory failure, acute kidney injury at the time of enrolment
• Chronic kidney disease, stage 5D (requiring continuous hemodialysis)
• Treatment with renal replacement therapy in the past 90 days
• Presence of cirrhosis (\>5 Child-Pugh score)
• Acute pulmonary embolism
• Acute myocardial infarction within 3 weeks before elective surgery
• Left ventricular ejection fraction (LVEF) less than 40% according to echocardiography
• Acute cerebrovascular accident within 3 weeks before elective surgery
• Pregnancy

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Russia

Location

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

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: The study will use a 1:1 stratified randomisation. The stratification will be based on the patient's stage of CKD at the time of enrolment (strata - stages 0-2, 3-4).

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: November 11, 2024
• Primary Completion: April 22, 2025
• Study Completion: May 6, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

RU (1)