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.
Acute pancreatitis remains a life-threatening disorder with a considerable risk of unfavorable outcomes. In patients with severe acute pancreatitis (SAP), hospital mortality ranges from 16% to 20% and may rise to 60% in cases complicated by multiple organ dysfunction (MOD). Progressive MOD, arising from systemic inflammatory response syndrome (SIRS), represents the principal cause of early death. Recently, extracorporeal blood purification techniques, including hemoperfusion, have emerged as valuable adjuncts to intensive care, providing opportunities to correct derangements in homeostasis. In recent years, extracorporeal blood purification methods, including hemoperfusion, have become one of the components of intensive care, allowing for correction of homeostatic parameters. The Efferon® LPS device was originally developed for use in sepsis, utilizing its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential for the treatment of acute pancreatitis, a condition characterized by a similarly complex inflammatory response. 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/hemodiafiltration, with the goal of reducing the severity of organ dysfunction in patients with acute pancreatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Efferon LPS will be administered in combination with either hemofiltration (HF) or hemodiafiltration (HDF). The choice between HF and HDF will be made by the investigator, based on the individual clinical situation.The therapy will be initiated within the first 24 hours after ICU admission and within 8 hours after patient enrollment.
Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', Russia
State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory
Krasnodar, Russia
V.P. Demikhov City Clinical Hospital No. 68
Moscow, Russia
S.S. Yudin City Clinical Hospital
Moscow, Russia
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russia
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, Russia
Perm regional clinical hospital
Perm, Russia
North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency
Saint Petersburg, Russia
SOFA score
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
Time frame: 1-7 days
Vasopressor free days
* Vasopressor free days = 0 if subject dies within 14 days of starting vasopressor support. * Vasopressor free days = 14 - x if vasopressor support is successfully discontinued x days after initiation. * Vasopressor free days = 0 if the subject requires vasopressor support for more than 14 days.
Time frame: 1-14 days
Horovitz oxygenation index
Value of oxygenation index (Pa02 / Fi02 (Pa). Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).
Time frame: 1-14 days
Cardiac index
Cardiac index = stroke volume (mL/beat) × heart rate (beats/min) / BSA (m²) BSA - body surface area
Time frame: 1-72 hours
Length of stay in the intensive care unit
Time (number of days) from randomization to transfer from the intensive care unit within 60 days.
Time frame: 1-60 days
Mechanical ventilation duration
* Ventilator-free days = 0 if subject dies within 28 days of mechanical ventilation. * Ventilator-free days = 28 - x if successfully liberated from ventilation x days after initiation. * Ventilator-free days = 0 if the subject is mechanically ventilated for \>28 days.
Time frame: 1-28 days
Renal replacement therapy (RRT) duration
* RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. * RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. * RRT-free days = 0 if the subject requires RRT for more than 28 days.
Time frame: 1-28 days
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