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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Russian Federation
V.P. Demikhov City Clinical Hospital No. 68
RECRUITING
Moscow
Contact Information
Primary
Alexandr Shelehov-Kravchenko, PhD, MD
alexandr.shelehov@gmail.com
+79636564765
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 60
Treatments
No_intervention: Baseline therapy
Basic therapy - the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis
Experimental: Basic therapy + Efferon CT + HVHF
Basic therapy, which is the routine practice of an institution for the treatment of patients with acute nonseptic pancreatitis in combination with extracorporeal hemoperfusion therapy (Efferon CT) and high-volume hemofiltration (HVHF).
Sponsors
Leads: Efferon JSC

This content was sourced from clinicaltrials.gov