Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

NCT07267169 | Not Yet Recruiting

• 1 other identifier: efferon-lps-2025-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Pancreatitis, Acute

Keywords

acute pancreatitis; hemoperfusion

Outcome Measures

Primary Outcomes (1)

• 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.

  1-7 days

Secondary Outcomes (6)

• Vasopressor free days

  1-14 days

• Horovitz oxygenation index

  1-14 days

• Cardiac index

  1-72 hours

• Length of stay in the intensive care unit

  1-60 days

• Mechanical ventilation duration

  1-28 days

Study Arms (2)

Baseline therapy+ HF/HDF

NO INTERVENTION

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

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

Interventions

Efferon LPS 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.

Baseline therapy + HF/HDF + Efferon LPS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (8)

Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

Kazan', 420064, Russia

Location

State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory

Krasnodar, 350012, Russia

Location

V.P. Demikhov City Clinical Hospital No. 68

Moscow, 115280, Russia

Location

S.S. Yudin City Clinical Hospital

Moscow, 115446, Russia

Location

N.I. Pirogov City Clinical Hospital No. 1

Moscow, Russia

Location

N.V. Sklifosovsky Research Institute for Emergency Medicine

Moscow, Russia

Location

Perm regional clinical hospital

Perm, 614045, Russia

Location

North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency

Saint Petersburg, 194291, Russia

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Vladimir Kiselev, PhD, MD

  N. V. Sklifosovsky Moscow Research Institute of Emergency

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

RU (8)