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
This trial does not accept healthy volunteersQualifiers
≤ 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
Design model
Parallel
Treatments tested in this trial
Efferon LPS
DeviceEfferon 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Baseline therapy+ HF/HDFNo intervention 0 interventions
Group B: Baseline therapy + HF/HDF + Efferon LPSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
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 days3
Cardiac index
Cardiac index = stroke volume (mL/beat) × heart rate (beats/min) / BSA (m²) BSA - body surface area
Time frame
1-72 hours4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov