Combination of Cytokine Hemosorption and High-volume Hemofiltration in Acute Pancreatitis

Launched by EFFERON JSC · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with acute pancreatitis, a serious condition that can cause significant inflammation and illness. The study aims to see if a combination of two procedures, called cytokine hemosorption and high-volume hemofiltration, can help reduce symptoms and improve organ function in people who are experiencing acute pancreatitis without infection or severe complications. This trial is important because severe acute pancreatitis can lead to high mortality rates, and current treatments mainly focus on relieving symptoms rather than addressing the underlying inflammation.

To be eligible for this trial, participants must be between 18 and 75 years old and diagnosed with acute pancreatitis, as confirmed by medical imaging. They should have moderate to severe symptoms and have started experiencing symptoms no more than three days before joining the study. Participants will receive the study treatment for at least four hours, and they will be closely monitored throughout the process. This trial is currently recruiting participants, so if you or a loved one meets the criteria, there may be an opportunity to contribute to important research that could improve treatment options for acute pancreatitis.

Gender

ALL

Eligibility 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).