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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline therapy+ HF/HDF | No Intervention | Basic therapy - which is the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis in combination with hemofiltration (HF) or hemodiafiltration (HDF) procedures. | |
| Baseline therapy + HF/HDF + Efferon LPS | Experimental | Patients will receive basic therapy (routine practice of an institution for the treatment of patients with uninfected acute pancreatitis), hemofiltration or hemodiafiltration procedures in combination with hemoadsorption therapy (Efferon LPS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efferon LPS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor free days |
| 1-14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandr Shelehov-Kravchenko, PhD, MD | Contact | +79636564765 | alexandr.shelehov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Kiselev, PhD, MD | N. V. Sklifosovsky Moscow Research Institute of Emergency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan | Recruiting | Kazan' | 420064 | Russia |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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Allocation of patients into groups will be done by stratified 1:1 randomisation.
Stratification factors will include the Sequential Organ Failure Assessment (SOFA) score, Computed Tomography Severity Index (CTSI), and blood lactate levels.
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| 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). |
| 1-14 days |
| Cardiac index | Cardiac index = stroke volume (mL/beat) × heart rate (beats/min) / BSA (m²) BSA - body surface area | 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. | 1-60 days |
| Mechanical ventilation duration |
| 1-28 days |
| Renal replacement therapy (RRT) duration |
| 1-28 days |
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| V.P. Demikhov City Clinical Hospital No. 68 | Recruiting | Moscow | 115280 | Russia |
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| S.S. Yudin City Clinical Hospital | Recruiting | Moscow | 115446 | Russia |
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| N.I. Pirogov City Clinical Hospital No. 1 | Recruiting | Moscow | Russia |
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| N.V. Sklifosovsky Research Institute for Emergency Medicine | Recruiting | Moscow | Russia |
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| Perm regional clinical hospital | Recruiting | Perm | 614045 | Russia |
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| North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency | Recruiting | Saint Petersburg | 194291 | Russia |
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