Cardiac DiseaseNCT06659289
Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass
A study testing Efferon LPS in people with Cardiac Disease and Multiple Organ Dysfunction Syndrome, run by Efferon JSC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Disease, Multiple Organ Dysfunction Syndrome
- What is being tested?
- Efferon LPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteRussia
- Study dates
- 11 Nov 2024to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Pavlov First Saint Petersburg State Medical University
Saint Petersburg
About this study
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
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.
Read the 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.
- Being tested
- Efferon LPS
- Keywords
- Hemoperfusion, Extracorporeal therapy, Lipopolysaccharide adsorption
- Medical subject headings
- Heart Diseases, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon LPSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-72 hours
Secondary outcomes (12)
Incidence of post-operative acute kidney injury
Incidence of post-operative acute kidney injury is verified by Acute Kidney Injury Network (AKIN) criteria
Measured: 0-72 hours
Renal function
Time (number of hours) to return to normal glomerular filtration rate (GFR)
Measured: 0-72 hours
Duration of renal replacement therapy
Duration (hours) of renal replacement therapy in patients with advanced acute kidney injury. The criteria for the end of replacement therapy is the restoration of spontaneous diuresis of more than 50 mL/hour without stimulation of diuresis with drugs or more than 2000 mL/day with stimulation.
Measured: 1-28 days
Mean arterial pressure
Mean arterial pressure mmHg (measured every 24 hours ±1 hour)
Measured: 0-72 hours
Duration of vasopressor support
Time (hours) to end of vasopressor support
Measured: 0-72 hours
Pulmonary oxygen metabolic function index
Measuring PaO2 / FiO2 index every 24 hours
Measured: 0-72 hours
Incidence of postperfusion heart failure
Incidence of postperfusion heart failure
Measured: 0-72 hours
Duration of the need for pharmacological and/or mechanical inotropic myocardial support
Duration (number of hours) of the need for pharmacological and/or mechanical inotropic myocardial support from the beginning of the operation to 72 hours.
Measured: 0-72 hours
Duration of ventilation
The time (hours) from the start of the operation until you are weaned off the ventilator within 14 days, or are discharged from hospital or transferred from intensive care (if earlier than day 14).
Measured: 1-14 days
ICU length of stay
Time (days) from the end of cardiopulmonary bypass to transfer from the ICU within 14 days or hospital discharge (if earlier than day 14)
Measured: 1-14 days
28-day mortality
The number of trial participants who died in intensive care or in hospital within 28 days of randomisation
Measured: Time from randomisation to 28 days from the moment of randomisation
Incidence of septic complications
The number of patients who were diagnosed with sepsis after the end of cardiopulmonary bypass in the post-operative period according to the Sepsis-3 criteria
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start11 Nov 2024
- Primary completion22 Apr 2025
- Study completion6 May 2025
Why it stopped: Terminated due to futility. Post-enrollment analysis of baseline disease severity indicated that the enrolled population would not allow for a meaningful assessment of the treatment effect on the primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuri Polushin, PhD,MD, Principal investigator, Pavlov First Saint Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659289
- Sponsor's protocol ID
- efferon-lps-2024-03
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06659289
- Acronym / sponsor ID
- efferon-lps-2024-03
- Keywords
- Hemoperfusion, Extracorporeal therapy, Lipopolysaccharide adsorption
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to futility. Post-enrollment analysis of baseline disease severity indicated that the enrolled population would not allow for a meaningful assessment of the treatment effect on the primary endpoint.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Efferon LPSPatients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoperfusion with Efferon LPS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned cardiac surgery (aortocoronary bypass, heart valve replacement, etc.) requiring the use of cardiopulmonary bypass
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon LPSEfferon 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. | Device | Basic therapy + Efferon LPS |
Primary outcome
Effect of the hemoperfusion with Efferon LPS device during cardiopulmonary bypass on measures of organ dysfunction
Time frame: 0-72 hours
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.
12 secondary outcomes
Incidence of post-operative acute kidney injury
Time frame: 0-72 hours
Renal function
Time frame: 0-72 hours
Duration of renal replacement therapy
Time frame: 1-28 days
Mean arterial pressure
Time frame: 0-72 hours
Duration of vasopressor support
Time frame: 0-72 hours
Pulmonary oxygen metabolic function index
Time frame: 0-72 hours
Incidence of postperfusion heart failure
Time frame: 0-72 hours
Duration of the need for pharmacological and/or mechanical inotropic myocardial support
Time frame: 0-72 hours
Duration of ventilation
Time frame: 1-14 days
ICU length of stay
Time frame: 1-14 days
28-day mortality
Time frame: Time from randomisation to 28 days from the moment of randomisation
Incidence of septic complications
Time frame: 1-14 days
Results and safety
The study was stopped early (reason given: Terminated due to futility. Post-enrollment analysis of baseline disease severity indicated that the enrolled population would not allow for a meaningful assessment of the treatment effect on the primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri Polushin, PhD,MD principal investigator
Pavlov First Saint Petersburg State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon LPS in people with Cardiac Disease and Multiple Organ Dysfunction Syndrome, run by Efferon JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to futility. Post-enrollment analysis of baseline disease severity indicated that the enrolled population would not allow for a meaningful assessment of the treatment effect on the primary endpoint.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the hemoperfusion with Efferon LPS device during cardiopulmonary bypass on measures of organ dysfunction (time frame: 0-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.