NCT07267169 Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
| NCT ID | NCT07267169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Efferon JSC |
| Condition | Pancreatitis, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-03-30 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion 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 Exclusion Criteria: * 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)
Contact & Investigator
Vladimir Kiselev, PhD, MD
PRINCIPAL INVESTIGATOR
N. V. Sklifosovsky Moscow Research Institute of Emergency
Frequently Asked Questions
Who can join the NCT07267169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07267169 currently recruiting?
Yes, NCT07267169 is actively recruiting participants. Contact the research team at alexandr.shelehov@gmail.com for enrollment information.
Where is the NCT07267169 trial being conducted?
This trial is being conducted at Kazan', Russia, Krasnodar, Russia, Moscow, Russia, Moscow, Russia and 4 additional locations.
Who is sponsoring the NCT07267169 clinical trial?
NCT07267169 is sponsored by Efferon JSC. The principal investigator is Vladimir Kiselev, PhD, MD at N. V. Sklifosovsky Moscow Research Institute of Emergency. The trial plans to enroll 150 participants.