Actively Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Led by Efferon JSC · Updated on 2026-04-07
150
Participants Needed
8
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute pancreatitis onset within 5 days or less
- Moderate or severe acute pancreatitis according to the Atlanta classification (2012)
- Acute pancreatitis confirmed by tomography with Modified CTSI Pancreatitis Severity Index Score of 4 or higher
- APACHE II score greater than 8
- SOFA score of 2 or more and/or at least 2 criteria of Systemic Inflammatory Response Syndrome (SIRS), including body temperature of 38 6C or higher or 36 6C or lower, heart rate 90/min or higher, respiratory rate 20/min or higher or hyperventilation with PaCO2 32 mmHg or lower, leukocytosis of 12,000/bcl or higher, leukopenia of 4,000/bcl or lower, or left shift of leukocyte formula
You will not qualify if you...
- SOFA score greater than 12
- Presence of uncontrolled surgical infection focus
- Development of septic complications or signs of infection
- Acute pancreatitis as an exacerbation of chronic pancreatitis
- Blood triglyceride level greater than 1000 mg/dL (11.2 mmol/L)
- Liver cirrhosis with Child-Pugh classification greater than 6 points
- Unresolved biliary hypertension syndrome
- Body mass index (BMI) of 40 or higher
- Dementia
- Chronic kidney disease stage 4 or 5
- Acute pulmonary embolism confirmed by CT
- Acute myocardial infarction within the last 4 weeks
- Acute cerebrovascular accident
- Severe congestive heart failure
- Uncontrolled bleeding within the last 24 hours
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', Russia, 420064
Actively Recruiting
2
State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory
Krasnodar, Russia, 350012
Actively Recruiting
3
V.P. Demikhov City Clinical Hospital No. 68
Moscow, Russia, 115280
Actively Recruiting
4
S.S. Yudin City Clinical Hospital
Moscow, Russia, 115446
Actively Recruiting
5
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
Actively Recruiting
6
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, Russia
Actively Recruiting
7
Perm regional clinical hospital
Perm, Russia, 614045
Actively Recruiting
8
North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency
Saint Petersburg, Russia, 194291
Actively Recruiting
Research Team
A
Alexandr Shelehov-Kravchenko, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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