Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis

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 groups

Locations

8
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan420064, Kazan' Russia
State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory350012, Krasnodar Russia
N.I. Pirogov City Clinical Hospital No. 1 Moscow Russia
N.V. Sklifosovsky Research Institute for Emergency Medicine Moscow Russia

Sponsors and collaborators

Efferon JSC

Lead sponsor