Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
ConditionPancreatitis, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEfferon JSC
About this trial
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.
Eligibility criteria
Qualifiers
≤ 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efferon LPS
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov