Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-19

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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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

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Pancreatitis, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baseline therapy+ HF/HDF

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Baseline therapy + HF/HDF + Efferon LPS

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).

Group Type EXPERIMENTAL

Efferon LPS

Intervention Type DEVICE

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.

Interventions

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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 24 hours after ICU admission and within 8 hours after patient enrollment.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No