Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

Efferon

Status: Not yet enrolling

Conditions: Pancreatitis, Acute

Treatments: Device: Efferon LPS

Study type: Interventional

Funder types: Industry

Identifiers

NCT07267169

efferon-lps-2025-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≤ 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Baseline therapy+ HF/HDF

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Device: Efferon LPS