Efferon LPS hemoadsorption with hemofiltration for acute pancreatitis
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
This trial will test whether adding Efferon LPS hemoadsorption to hemofiltration/hemodiafiltration helps patients with moderate-to-severe acute pancreatitis reduce organ dysfunction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 8 sites (Kazan' and 7 other locations) |
| Trial ID | NCT07267169 on ClinicalTrials.gov |
What this trial studies
This interventional study compares standard hemofiltration/hemodiafiltration (HF/HDF) alone to HF/HDF combined with Efferon LPS multimodal hemoadsorption in patients with moderate-to-severe acute pancreatitis. Participants are assigned to a control group (HF/HDF alone) or a treatment group (HF/HDF plus Efferon LPS) and therapy is started within 24 hours of ICU admission and within 8 hours of enrollment. The main outcome is change in organ dysfunction measured by the SOFA score, and safety endpoints are collected alongside efficacy measures. The Efferon LPS device targets both cytokines and lipopolysaccharide to reduce systemic inflammation that can drive multiple organ dysfunction.
Who should consider this trial
Good fit: Ideal candidates are patients within five days of pancreatitis onset with moderate or severe disease by the 2012 Atlanta criteria, CT-confirmed pancreatitis with modified CTSI ≥4, APACHE II >8, and either SOFA ≥2 or at least two SIRS criteria.
Not a fit: Patients with SOFA >12, uncontrolled surgical infection, septic complications, exacerbation of chronic pancreatitis, very high triglycerides (>1000 mg/dL), advanced cirrhosis, or other listed exclusions are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, adding Efferon LPS could reduce the severity of organ dysfunction and may lower ICU stays and mortality in severe acute pancreatitis.
How similar studies have performed: Hemoadsorption and extracorporeal blood-purification approaches have shown promising but mixed results in sepsis and inflammatory conditions, and their application to acute pancreatitis is plausible but not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Kazan' and 7 other locations
- Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan — Kazan', Russia (Recruiting)
- State Clinical Hospital "Regional Clinical Hospital No 2" of the Ministry of Healthcare of Krasnodar Territory — Krasnodar, Russia (Recruiting)
- V.P. Demikhov City Clinical Hospital No. 68 — Moscow, Russia (Recruiting)
- S.S. Yudin City Clinical Hospital — Moscow, Russia (Recruiting)
- N.I. Pirogov City Clinical Hospital No. 1 — Moscow, Russia (Recruiting)
- N.V. Sklifosovsky Research Institute for Emergency Medicine — Moscow, Russia (Recruiting)
- Perm regional clinical hospital — Perm, Russia (Recruiting)
- North-Western district scientific and clinical center named after L. G. Sokolov Federal Medical and Biological Agency — Saint Petersburg, Russia (Recruiting)
Study contacts
- Principal investigator: Vladimir Kiselev, PhD, MD — N. V. Sklifosovsky Moscow Research Institute of Emergency
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +79636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.