Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
Efferon JSC
150 participants
Mar 30, 2026
INTERVENTIONAL
Conditions
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 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 24 hours after ICU admission and within 8 hours after patient enrollment.
Eligibility
Inclusion Criteria9
- ≤ 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
- APACHE II > 8
- ≥ 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
Exclusion Criteria15
- 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)
- 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)
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Interventions
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 24 hours after ICU admission and within 8 hours after patient enrollment.
Locations(8)
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NCT07267169