Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass

NCT ID: NCT06659289

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2025-05-06

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.

Detailed Description

Every year, more than 1 million people around the world undergo heart surgery. Cardiac surgery still requires cardiopulmonary bypass in the majority of cases for a number of reasons. The use of cardiopulmonary bypass in cardiothoracic surgery is a well-known and potent inducer of immune responses due to the contact of whole blood with air and extracorporeal circuit surfaces, ischemia-reperfusion injury, hemolysis and release of free hemoglobin, the effects of surgical trauma itself, and other factors.The activation of immune cells leads to the release of cytokines and inflammatory mediators such as IL-6, IL-8, activated complement and others.

One of the most common post-operative complications associated with the administration of cardiopulmonary bypass during surgery is acute kidney injury (AKI). AKI develops in 30% of patients undergoing cardiac surgery and is associated with high mortality, longer hospital stay, dialysis dependency, high risk of infectious complications and ultimately poor quality of life. 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.

Currently, hemosorbents based on highly cross-linked styrene/divinylbenzene copolymers can remove endo- and exotoxins in sepsis and acute and chronic renal and hepatic failure, remove intoxication by pharmacological drugs, narcotics and poisons, and remove cytokines produced in excess in systemic inflammatory syndromes of various aetiologies, including systemic inflammatory response syndrome after open-heart surgery with cardiopulmonary bypass.

Hemoperfusion is a method of extracorporeal removal of toxic substances from the blood by adsorption to a porous material. Hemoperfusion can be a good complement or substitute to the classical methods of hemofiltration and hemodialysis when diffusion or convection of toxic substances through the membrane is not efficient enough.

Based on previous studies, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Basic therapy + Efferon LPS

Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoperfusion with Efferon LPS.

Group Type: EXPERIMENTAL

Efferon LPS

Intervention Type: 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.

Interventions

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Any other clinical condition of the patient that, in the opinion of the investigator, precludes inclusion in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuri Polushin, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Pavlov First Saint Petersburg State Medical University

Locations

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

efferon-lps-2024-03

Identifier Type: -

Identifier Source: org_study_id