Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

Official title

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis

Overview

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.

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.

Interventions

• 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 24 hours after ICU adm

Primary outcome measures

• SOFA score [Time frame: 1-7 days]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 8 centers

• Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan — Kazan'
• State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of — Krasnodar
• V.P. Demikhov City Clinical Hospital No. 68 — Moscow
• S.S. Yudin City Clinical Hospital — Moscow
• N.I. Pirogov City Clinical Hospital No. 1 — Moscow
• N.V. Sklifosovsky Research Institute for Emergency Medicine — Moscow
• Perm regional clinical hospital — Perm
• North-Western district scientific and clinical center named after L. G. Sokolov Federal Me — Saint Petersburg

Identifiers

NCT: NCT07267169 · efferon-lps-2025-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗