Clinical trial NCT06659289: Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass
Official title: Efficacy and Safety of Lipopolysaccharide Adsorption (Efferon LPS) During Cardiac Surgery Using Cardiopulmonary Bypass to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Multiple Organ Dysfunction Syndrome
Keywords: Hemoperfusion
Extracorporeal therapy
Lipopolysaccharide adsorption
Lead sponsor: Efferon JSC
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of the hemoperfusion with Efferon LPS device during cardiopulmonary bypass on measures of organ dysfunction
timeFrame: 0-72 hours
Secondary outcomes:
measure: Incidence of post-operative acute kidney injury
timeFrame: 0-72 hours
measure: Renal function
timeFrame: 0-72 hours
measure: Duration of renal replacement therapy
timeFrame: 1-28 days
measure: Mean arterial pressure
timeFrame: 0-72 hours
measure: Duration of vasopressor support
timeFrame: 0-72 hours
measure: Pulmonary oxygen metabolic function index
timeFrame: 0-72 hours
measure: Incidence of postperfusion heart failure
timeFrame: 0-72 hours
measure: Duration of the need for pharmacological and/or mechanical inotropic myocardial support
timeFrame: 0-72 hours
measure: Duration of ventilation
timeFrame: 1-14 days
measure: ICU length of stay
timeFrame: 1-14 days
measure: 28-day mortality
timeFrame: Time from randomisation to 28 days from the moment of randomisation
measure: Incidence of septic complications
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
Study officials:
affiliation: Pavlov First Saint Petersburg State Medical University
name: Yuri Polushin, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: