Actively Recruiting
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
Led by Efferon JSC · Updated on 2026-04-07
150
Participants Needed
8
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a blood purification method called multimodal hemoperfusion using the Efferon4 LPS device along with hemofiltration (HF) or hemodiafiltration (HDF) in patients with acute pancreatitis. This study aims to reduce the severity of organ dysfunction, measured by the SOFA score, in this serious condition that can lead to multiple organ failure and high mortality. The Efferon4 LPS device targets inflammatory substances involved in acute pancreatitis, which is characterized by a complex inflammatory response. Participants will be randomly assigned to one of two groups: one receiving standard care with HF or HDF alone, and the other receiving the same baseline therapy combined with the Efferon4 LPS hemoadsorption treatment. The therapy will begin within 24 hours of ICU admission and within 8 hours after enrollment. The choice between HF and HDF will be made by the treating physician based on individual patient needs. During the study, participants will be closely monitored with assessments including SOFA scores over 1 to 7 days, vasopressor-free days, oxygenation index, cardiac index, ICU stay length, mechanical ventilation duration, and renal replacement therapy duration. These measures will help evaluate the treatment's impact on organ function and patient recovery. The overall study period includes follow-up monitoring up to 60 days. The study does not include healthy volunteers and targets adults aged 18 to 75 with moderate to severe acute pancreatitis.
CONDITIONS
Brief Title
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 5 days or less since acute pancreatitis began
- Acute pancreatitis classified as moderate or severe by the Atlanta classification (2012)
- Diagnosis confirmed by tomography with a 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 Systemic Inflammatory Response Syndrome (SIRS) criteria: 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
- Age between 18 and 75 years
You will not qualify if you...
- SOFA score greater than 12 points
- Uncontrolled surgical infection focus
- Signs of septic complications or infection
- Acute pancreatitis caused by exacerbation of chronic pancreatitis
- Blood triglyceride level greater than 1000 mg/dL (11.2 mmol/L)
- Liver cirrhosis with Child-Pugh score greater than 6
- 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 with acute blood loss within the last 24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive hemofiltration or hemodiafiltration procedures in combination with the Efferon LPS hemoadsorption device initiated within the first 24 hours after ICU admission and within 8 hours after enrollment.
Daily visits during treatment
Duration - Up to 60 days
Participants are monitored for clinical outcomes such as organ function, length of ICU stay, and duration of mechanical ventilation and renal replacement therapy after treatment ends.
Weekly visits or assessments during ICU stay and follow-up
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
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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