An interventional study of Efferon LPS in Pancreatitis, Acute, sponsored by Efferon JSC. Recruiting at 8 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Efferon JSC · Not applicable, Interventional, and Treatment
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.
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Efferon JSC is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 2, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Device: 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. 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.
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.
Time frame: 1-7 days
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.
Time frame: 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).
Time frame: 1-14 days
Cardiac index
Cardiac index = stroke volume (mL/beat) × heart rate (beats/min) / BSA (m²) BSA - body surface area
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1-28 days
Started Mar 2026 (actual). Primary completion is estimated for Jan 2028, 22 months after the start.
Of 94 interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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