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NCT07267169
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Conditions: Pancreatitis, Acute
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Efferon JSC
Location: Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan Kazan'
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 48 hours after ICU admission and within 8 hours after patient enrollment.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07267169). StuddyBuddy aggregates publicly available trial information.