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Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

RecruitingNAAges 18 Years - 75 YearsAllEfferon JSC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Efferon LPS
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Where

8 sites
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', Russia
State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory
Krasnodar, Russia
V.P. Demikhov City Clinical Hospital No. 68
Moscow, Russia
S.S. Yudin City Clinical Hospital
Moscow, Russia
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, Russia
Perm regional clinical hospital
Perm, Russia
North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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