Hemoperfusion Efferon СT for the Treatment of Patients With Acute Pancreatitis

NCT05695001 | Completed

• 1 other identifier: efferon-ct-2022-02
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pancreatitis With Uninfected Necrosis, Unspecified

Keywords

acute pancreatitis; sepsis; cytokine sorption; endogenous intoxication

Outcome Measures

Primary Outcomes (1)

• Effect of Efferon CT hemoperfusion on SOFA scores (Sequential Organ Failure Assessment) in patients with acute pancreatitis.

  The value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 72 hours. The SOFA index is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall index, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA index, the less pronounced organ failure and the better the patient's survival prognosis.

  1-72 hours

Secondary Outcomes (2)

• The effect of Efferon CT hemoperfusion on length of stay in the intensive care unit

  1-14 days

• Effect of Efferon hemoperfusion on interleukin levels (IL-1b, IL-6, IL-8, IL-10, IL-18)

  1-72 hours

Study Arms (2)

No Intervention: Baseline therapy

Basic therapy is the routine practice of an institution for the treatment of patients with acute pancreatitis without signs of infection

Experimental: Basic therapy + Efferon CT

Basic therapy is a routine practice of the institution for the treatment of patients with acute uninfected pancreatitis in combination with extracorporeal hemoperfusion (Efferon CT)

Device: Efferon CT

Interventions

Efferon CT DEVICE

Efferon CT is a cylindrical body made of polycarbonate, filled with spherical granules of polymer hemocompatible macroporous styrene-divinylbenzene copolymer of super cross-linked type and isotonic sodium chloride solution. The device is manufactured according to TU 32.50.50-001-12264678-2018, has passed the necessary tests and is registered in Russia as a medical product RZN 2019/8886.

Experimental: Basic therapy + Efferon CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both sexes over 18 years of age with signs of acute pancreatitis no later than 72 hours from the onset of an attack of pain without signs of an infectious process

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

N.V. Sklifosovsky Moscow Research Institute of Emergency

Moscow, Russia

Location

MeSH Terms

Conditions

Pancreatitis; Sepsis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Kiselev, PhD, MD

  N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 23, 2023
• Study Start: January 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

RU (1)