Treatment for acute pancreatitis using cytokine hemosorption and hemofiltration
An Open Controlled Randomized Study of the Efficacy and Safety of the Method of Combined Use of Non-selective Hemosorption (Efferon CT) and High Volume Hemofiltration (HVHF) in Patients With Acute Pancreatitis.
This study tests if a new treatment using special filters can help people with acute pancreatitis feel better and avoid serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05694988 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of cytokine hemosorption and high-volume hemofiltration on patients suffering from acute pancreatitis without necrosis or infection. The approach aims to mitigate the severe inflammatory response associated with the condition, which can lead to multiple organ failure and increased mortality. By utilizing extracorporeal removal of cytokines, the study seeks to improve patient outcomes during the critical early phase of the disease. Participants will be monitored for changes in symptoms and organ dysfunction indicators following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with acute pancreatitis confirmed by imaging and without signs of infection.
Not a fit: Patients over 75 years old or those with chronic pancreatitis exacerbations will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and improve recovery rates for patients with acute pancreatitis.
How similar studies have performed: While the approach of cytokine removal is promising, it remains largely novel and untested in this specific context of acute pancreatitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 75 years old, * Acute pancreatitis according to the Atlanta classification of OP (2012), without signs of infection, * Acute pancreatitis confirmed by tomography. Score according to the Modified CTSI Pancreatitis Severity Index: from 4 points and above, * No more than 3 days from the onset of an attack of acute pancreatitis, * APACHE II score - at least 10, * The patient must receive adequate fluid therapy (at least 30 ml/kg) from the time of randomization until the first therapy, * The patient's condition allows therapy for at least 4 hours. Exclusion Criteria: * Age over 75, * More than 3 days from the onset of an attack of acute pancreatitis, * An attack of acute pancreatitis, as an exacerbation of chronic pancreatitis. * Acute pancreatitis as a complication of a surgical operation, * DS - Septic shock (Sepsis-3, 2016) * The presence of a focus of non-sanitized surgical infection, * Charlson comorbidity index\> 5 points, * Critical hypoxemia (PaO2/FiO2 \< 150 mm Hg), * GCS level of consciousness \< 12 points, * Obesity 3 degrees and above (weight over 150 kg), * Blood triglyceride level \>1000 mg/dl, (11.2 mmol/l), * Dementia, * Inability to achieve or maintain min SBP ≥ 65 mm Hg. Art., despite vasopressor therapy and infusion therapy in tech. 24 hours * Presence of end-stage renal disease requiring RRT, * The presence of cirrhosis of the liver (\> 5 points according to the Child-Pugh classification), * Unresolved biliary hypertension syndrome, * Acute thromboembolism of the pulmonary artery, confirmed by tomography, * Acute myocardial infarction within the last 4 weeks, * Acute cerebrovascular accident, * Transfusion reaction, * Severe congestive heart failure, * Uncontrolled bleeding (acute blood loss in the last 24 hours).
Where this trial is running
Moscow
- V.P. Demikhov City Clinical Hospital No. 68 — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Makariy Mendibaev, MD — Demikhov City Clinical Hospital of the Moscow Health Department
- 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.