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NCT05695001
Hemoperfusion Efferon СT for the Treatment of Patients With Acute Pancreatitis
Conditions: Acute Pancreatitis With Uninfected Necrosis, Unspecified
Sex: All
Ages: 18 Years – N/A
Enrollment: 40
Sponsor: Efferon JSC
Location: Russian Federation
Summary
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 at a later stage of the disease.With regard to the pronounced inflammatory response ("cytokine storm") during the early phase of endogenous intoxication of acute pancreatitis, extracorporeal removal of cytokines is a promising therapeutic approach.This prospective study examines the effect of early extracorporeal sorption of cytokines using the Efferon CT device on the severity of clinical symptoms of endogenous intoxication in acute pancreatitis and aseptic pancreatic necrosis.
Eligibility Criteria
Inclusion Criteria:Age ≥18 years old,Verified diagnosis of "Acute pancreatitis" according to the Atlanta classification of acute pancreatitis (2012), without signs of infection,No more than 72 hours from the onset of an attack of acute pancreatitis to hemosorption,The patient's condition allows for therapy with the Efferon CT device for at least 4 hours.Exclusion Criteria:History of chronic pancreatitis (exacerbation of chronic pancreatitis),The presence of a focus of non-sanitized surgical infection,The use of other methods of extracorporeal removal of inflammatory mediators in the treatment of pancreatitis (hemofilters with highly permeable and surface-modified membranes),Inability to achieve or maintain a minimum mean arterial pressure (MAP) ≥ 65 mmHg.
Art., despite vasopressor therapy and infusion therapy for 24 hours,End-stage renal disease, and the need for chronic dialysis,Acute pulmonary embolism,Transfusion reaction,Severe congestive heart failure,The patient has had an acute myocardial infarction within the last 4 weeks,Uncontrolled bleeding (acute blood loss in the last 24 hours),Severe granulocytopenia (white blood cell count less than 500 cells/mm3) or severe thrombocytopenia,Oncopathology out of remission.
Source: ClinicalTrials.gov (NCT05695001). StuddyBuddy aggregates publicly available trial information.