Pancreatitis, AcuteNCT07267169
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
A study testing Efferon LPS in people with Pancreatitis, Acute, run by Efferon JSC at 8 sites in Russia.
Trial summary
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration (HF) / hemodiafiltration (HDF), with the goal of reducing the severity of organ dysfunction (measured by SOFA score) in patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatitis, Acute
- 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
- 150 participants
- Where
- 8 sitesRussia
- Study dates
- 30 Mar 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≤ 5 days from the onset of acute pancreatitis
- Acute pancreatitis of moderate or severe according to the Atlanta classification (2012)
- Acute pancreatitis confirmed by tomography. Modified CTSI Pancreatitis Severity Index Score ≥ 4 points
- ≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
- Body temperature ≥ 38 °C or ≤ 36 °C
- Heart rate ≥ 90/min
- Respiratory rate ≥ 20/min or hyperventilation with PaCO₂ ≤ 32 mmHg
- Leukocytosis (≥ 12,000/μl) or leukopenia (≤ 4,000/μl) or left shift of leukocyte formula
Who cannot join
- SOFA score > 12 points
- Presence of an uncontrolled surgical infection focus
- Development of septic complications - signs of infection
- Acute pancreatitis as an exacerbation of chronic pancreatitis
- Blood triglyceride level > 1000 mg/dL (11.2 mmol/L)
- Liver cirrhosis (> 6 points by Child-Pugh classification)
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- Unresolved biliary hypertension syndrome
- BMI ≥ 40
- Dementia
- Chronic kidney disease stage 4-5
- Acute pulmonary embolism confirmed by CT
- Acute myocardial infarction within the last 4 weeks
- Acute cerebrovascular accident
- Severe congestive heart failure
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Russia8 sites, 8 recruiting
- Recruiting
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', 420064
Ruslan Zefirov, PhD, MD, ruslan.zefirov@tatar.ru
- Recruiting
State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory
Krasnodar, 350012
Sergey Sinkov, PhD, MD, ssinkov@yandex.ru
- Recruiting
V.P. Demikhov City Clinical Hospital No. 68
Moscow, 115280
Makariy Mendibaev, PhD, MD, makariy.mendibaev@yandex.ru
- Recruiting
S.S. Yudin City Clinical Hospital
Moscow, 115446
Nikolai Krotenko, PhD, MD, npkrotenko@gmail.com
- Recruiting
N.I. Pirogov City Clinical Hospital No. 1
Moscow
Marat Magomedov, PhD, MD, mma16@bk.ru
- Recruiting
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow
Sergey Rey, PhD, MD, fanwal@mail.ru
- Recruiting
Perm regional clinical hospital
Perm, 614045
Alexey Vereshchagin, PhD, MD, veralex.80@mail.ru
- Recruiting
North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency
Saint Petersburg, 194291
Ionas Simutis, PhD, MD, simutis@mail.ru
About this study
Official title: Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration (HF) / hemodiafiltration (HDF), with the goal of reducing the severity of organ dysfunction (measured by SOFA score) in patients with acute pancreatitis.
Participants will be assigned to two groups for comparison: a control group receiving baseline therapy with HF/HDF, and a treatment group receiving baseline therapy in combination with HF/HDF and Efferon® LPS hemoadsorption.The therapy will be initiated within the first 48 hours after ICU admission and within 8 hours after patient enrollment.
Read the detailed description
Acute pancreatitis remains a life-threatening disorder with a considerable risk of unfavorable outcomes. In patients with severe acute pancreatitis (SAP), hospital mortality ranges from 16% to 20% and may rise to 60% in cases complicated by multiple organ dysfunction (MOD). Progressive MOD, arising from systemic inflammatory response syndrome (SIRS), represents the principal cause of early death. Recently, extracorporeal blood purification techniques, including hemoperfusion, have emerged as valuable adjuncts to intensive care, providing opportunities to correct derangements in homeostasis.
In recent years, extracorporeal blood purification methods, including hemoperfusion, have become one of the components of intensive care, allowing for correction of homeostatic parameters.
The Efferon® LPS device was originally developed for use in sepsis, utilizing its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential for the treatment of acute pancreatitis, a condition characterized by a similarly complex inflammatory response.
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration/hemodiafiltration, with the goal of reducing the severity of organ dysfunction in patients with acute pancreatitis.
- Conditions
- Pancreatitis, Acute
- Being tested
- Efferon LPS
- Keywords
- acute pancreatitis, hemoperfusion
- Medical subject headings
- Pancreatitis
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.
Efferon LPS will be administered in combination with either hemofiltration (HF) or hemodiafiltration (HDF). The choice between HF and HDF will be made by the investigator, based on the individual clinical situation.The therapy will be initiated within the first 48 hours after ICU admission and within 8 hours after patient enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Baseline therapy+ HF/HDF | No intervention | Basic therapy - which is the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis in combination with hemofiltration (HF) or hemodiafiltration (HDF) procedures. |
| Baseline therapy + HF/HDF + Efferon LPS | Experimental | Patients will receive basic therapy (routine practice of an institution for the treatment of patients with uninfected acute pancreatitis), hemofiltration or hemodiafiltration procedures in combination with hemoadsorption therapy (Efferon LPS). Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score
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.
Measured: 1-7 days
Secondary outcomes (6)
Vasopressor free days
- Vasopressor free days = 0 if subject dies within 14 days of starting vasopressor support.
- Vasopressor free days = 14 - x if vasopressor support is successfully discontinued x days after initiation.
- Vasopressor free days = 0 if the subject requires vasopressor support for more than 14 days.
Measured: 1-14 days
Horovitz oxygenation index
Value of oxygenation index (Pa02 / Fi02 (Pa).
Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).
Measured: 1-14 days
Cardiac index
Cardiac index = stroke volume (mL/beat) × heart rate (beats/min) / BSA (m²)
BSA - body surface area
Measured: 1-72 hours
Length of stay in the intensive care unit
Time (number of days) from randomization to transfer from the intensive care unit within 60 days.
Measured: 1-60 days
Mechanical ventilation duration
- Ventilator-free days = 0 if subject dies within 28 days of mechanical ventilation.
- Ventilator-free days = 28 - x if successfully liberated from ventilation x days after initiation.
- Ventilator-free days = 0 if the subject is mechanically ventilated for >28 days.
Measured: 1-28 days
Renal replacement therapy (RRT) duration
- RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy.
- RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation.
- RRT-free days = 0 if the subject requires RRT for more than 28 days.
Measured: 1-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Mar 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies 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
- Allocation of patients into groups will be done by stratified 1:1 randomisation. Stratification factors will include the Sequential Organ Failure Assessment (SOFA) score, Computed Tomography Severity Index (CTSI), and blood lactate levels.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Kiselev, PhD, MD, Principal investigator, N. V. Sklifosovsky Moscow Research Institute of Emergency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267169
- Sponsor's protocol ID
- efferon-lps-2025-02
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT07267169
- Acronym / sponsor ID
- efferon-lps-2025-02
- Conditions
- Pancreatitis, Acute
- Keywords
- acute pancreatitis, hemoperfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Dec 2025 (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.
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration (HF) / hemodiafiltration (HDF), with the goal of reducing the severity of organ dysfunction (measured by SOFA score) in patients with acute pancreatitis.
Participants will be assigned to two groups for comparison: a control group receiving baseline therapy with HF/HDF, and a treatment group receiving baseline therapy in combination with HF/HDF and Efferon® LPS hemoadsorption.The therapy will be initiated within the first 48 hours after ICU admission and within 8 hours after patient enrollment.
Detailed description
Acute pancreatitis remains a life-threatening disorder with a considerable risk of unfavorable outcomes. In patients with severe acute pancreatitis (SAP), hospital mortality ranges from 16% to 20% and may rise to 60% in cases complicated by multiple organ dysfunction (MOD). Progressive MOD, arising from systemic inflammatory response syndrome (SIRS), represents the principal cause of early death. Recently, extracorporeal blood purification techniques, including hemoperfusion, have emerged as valuable adjuncts to intensive care, providing opportunities to correct derangements in homeostasis.
In recent years, extracorporeal blood purification methods, including hemoperfusion, have become one of the components of intensive care, allowing for correction of homeostatic parameters.
The Efferon® LPS device was originally developed for use in sepsis, utilizing its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential for the treatment of acute pancreatitis, a condition characterized by a similarly complex inflammatory response.
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration/hemodiafiltration, with the goal of reducing the severity of organ dysfunction in patients with acute pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation of patients into groups will be done by stratified 1:1 randomisation. Stratification factors will include the Sequential Organ Failure Assessment (SOFA) score, Computed Tomography Severity Index (CTSI), and blood lactate levels.
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy+ HF/HDF | No intervention | –Basic therapy - which is the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis in combination with hemofiltration (HF) or hemodiafiltration (HDF) procedures. |
| Baseline therapy + HF/HDF + Efferon LPS | Experimental | Device: Efferon LPSPatients will receive basic therapy (routine practice of an institution for the treatment of patients with uninfected acute pancreatitis), hemofiltration or hemodiafiltration procedures in combination with hemoadsorption therapy (Efferon LPS). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≤ 5 days from the onset of acute pancreatitis
- Acute pancreatitis of moderate or severe according to the Atlanta classification (2012)
- Acute pancreatitis confirmed by tomography. Modified CTSI Pancreatitis Severity Index Score ≥ 4 points
- ≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
- Body temperature ≥ 38 °C or ≤ 36 °C
Key exclusion criteria (15 listed)
- SOFA score > 12 points
- Presence of an uncontrolled surgical infection focus
- Development of septic complications - signs of infection
- Acute pancreatitis as an exacerbation of chronic pancreatitis
- Blood triglyceride level > 1000 mg/dL (11.2 mmol/L)
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. Efferon LPS will be administered in combination with either hemofiltration (HF) or hemodiafiltration (HDF). The choice between HF and HDF will be made by the investigator, based on the individual clinical situation.The therapy will be initiated within the first 48 hours after ICU admission and within 8 hours after patient enrollment. | Device | Baseline therapy + HF/HDF + Efferon LPS |
Primary outcome
SOFA score
Time frame: 1-7 days
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.
6 secondary outcomes
Vasopressor free days
Time frame: 1-14 days
Horovitz oxygenation index
Time frame: 1-14 days
Cardiac index
Time frame: 1-72 hours
Length of stay in the intensive care unit
Time frame: 1-60 days
Mechanical ventilation duration
Time frame: 1-28 days
Renal replacement therapy (RRT) duration
Time frame: 1-28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Vladimir Kiselev, PhD, MD principal investigator
N. V. Sklifosovsky Moscow Research Institute of Emergency
8 sites 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 Pancreatitis, Acute, run by Efferon JSC at 8 sites 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 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandr Shelehov-Kravchenko, PhD, MD (+79636564765, alexandr.shelehov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score (time frame: 1-7 days). 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 2 Nov 2026.