Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05694988

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

Led by Efferon JSC · Updated on 2025-02-27

60

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 75 years old
  • Acute pancreatitis without infection according to the 2012 Atlanta classification
  • Acute pancreatitis confirmed by tomography with Modified CTSI score of 4 or higher
  • Onset of acute pancreatitis attack within the last 3 days
  • APACHE II score of at least 10
  • Receiving adequate fluid therapy (at least 30 ml/kg) from randomization until therapy
  • Condition allows therapy lasting at least 4 hours
Not Eligible

You will not qualify if you...

  • Age over 75 years old
  • Onset of acute pancreatitis attack more than 3 days ago
  • Acute pancreatitis due to chronic pancreatitis exacerbation
  • Acute pancreatitis following surgical operation
  • Septic shock (Sepsis-3, 2016)
  • Presence of untreated surgical infection
  • Charlson comorbidity index greater than 5
  • Critical hypoxemia (PaO2/FiO2 less than 150 mm Hg)
  • Glasgow Coma Scale less than 12
  • Obesity grade 3 or higher (weight over 150 kg)
  • Blood triglyceride level over 1000 mg/dl
  • Dementia
  • Inability to maintain minimum systolic blood pressure of 65 mm Hg despite therapy
  • End-stage renal disease requiring renal replacement therapy
  • Liver cirrhosis (Child-Pugh score over 5)
  • Unresolved biliary hypertension syndrome
  • Acute pulmonary artery thromboembolism confirmed by tomography
  • Acute myocardial infarction within last 4 weeks
  • Acute stroke
  • Transfusion reaction
  • Severe congestive heart failure
  • Uncontrolled bleeding within last 24 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

V.P. Demikhov City Clinical Hospital No. 68

Moscow, Russia, 109263

Actively Recruiting

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Research Team

A

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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