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New treatment option for Pancreatitis, Acute
Official title Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
ClinicalTrials.gov ID: NCT07267169
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- ≤ 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
- ≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
You likely can't join if
- 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
- Blood triglyceride level \> 1000 mg/dL (11.2 mmol/L)
- Liver cirrhosis (\> 6 points by Child-Pugh classification)
See the full eligibility criteria
- ≤ 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
- ≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
- Body temperature ≥ 38 °C or ≤ 36 °C
- Heart rate ≥ 90/min
- Respiratory rate ≥ 20/min or hyperventilation with PaCO₂ ≤ 32 mmHg
- Leukocytosis (≥ 12,000/μl) or leukopenia (≤ 4,000/μl) or left shift of leukocyte formula
- 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
- Blood triglyceride level \> 1000 mg/dL (11.2 mmol/L)
- Liver cirrhosis (\> 6 points by Child-Pugh classification)
- Unresolved biliary hypertension syndrome
- BMI ≥ 40
- Dementia
- Chronic kidney disease stage 4-5
- Acute pulmonary embolism confirmed by CT
- Acute myocardial infarction within the last 4 weeks
- Acute cerebrovascular accident
- Severe congestive heart failure
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
The study team makes the final eligibility decision.
Where it's taking place
- Kazan', Russia
- Krasnodar, Russia
- Moscow, Russia
- Perm, Russia
- Saint Petersburg, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kazan', Russia; Krasnodar, Russia; Moscow, Russia; Perm, Russia; Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.