Efferon LPS hemoadsorption with hemofiltration for acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares standard hemofiltration/hemodiafiltration (HF/HDF) alone to HF/HDF combined with Efferon LPS multimodal hemoadsorption in patients with moderate-to-severe acute pancreatitis. Participants are assigned to a control group (HF/HDF alone) or a treatment group (HF/HDF plus Efferon LPS) and therapy is started within 24 hours of ICU admission and within 8 hours of enrollment. The main outcome is change in organ dysfunction measured by the SOFA score, and safety endpoints are collected alongside efficacy measures. The Efferon LPS device targets both cytokines and lipopolysaccharide to reduce systemic inflammation that can drive multiple organ dysfunction.

Why it matters

Who can join: the full rules

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
* ≥ 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)

Where it's running

• Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
  Kazan', Russia Recruiting
• State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory
  Krasnodar, Russia Recruiting
• V.P. Demikhov City Clinical Hospital No. 68
  Moscow, Russia Recruiting
• S.S. Yudin City Clinical Hospital
  Moscow, Russia Recruiting
• N.I. Pirogov City Clinical Hospital No. 1
  Moscow, Russia Recruiting
• N.V. Sklifosovsky Research Institute for Emergency Medicine
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Vladimir Kiselev, PhD, MD — N. V. Sklifosovsky Moscow Research Institute of Emergency
• Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
• Email: alexandr.shelehov@gmail.com
• Phone: +79636564765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.