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

Recruiting now · Not applicable

Conditions studied: Acute Pancreatitis Without Necrosis or Infection

In brief

Mortality from severe acute pancreatitis reaches 42%. The prognosis of acute pancreatitis is associated with the development of acute inflammatory response syndrome (SIRS) and multiple organ failure (MOF). Due to the lack of etiological therapy, the treatment of acute pancreatitis is predominantly symptomatic. Severity and mortality are associated with early systemic inflammatory response syndrome (SIRS) and septic complications in the later stages of the disease. In connection with a pronounced inflammatory reaction ("cytokine storm") in the early phase of endogenous intoxication of acute pancreatitis, a promising therapeutic approach is the extracorporeal removal of cytokines. This prospective study intends to study the effect of hemoperfusion (Efferon CT) in combination with high-volume hemofiltration (HVHF) on the severity of symptoms of endogenous intoxication and indicators of organ dysfunction in acute pancreatitis.

Key facts

Study ID

NCT05694988

Run by

Efferon JSC

People needed

60

Starts

2022-11-01

Expected to finish

2026-04-30

Last updated by the study team

2025-02-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• V.P. Demikhov City Clinical Hospital No. 68 — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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