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

NCT05694988 | Recruiting DMC

• 1 other identifier: efferon-ct-2022-03
• Study Type: interventional
• Target: 60
• 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 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

Acute Pancreatitis Without Necrosis or Infection

Keywords

acute pancreatitis; sepsis; cytokines apsorbtion; hemoperfusion

Outcome Measures

Primary Outcomes (1)

• Effect of the combined use of the Efferon CT device and HVHF on indicators of organ dysfunction

  The value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 72 hours.

  1-72 hours

Secondary Outcomes (3)

• Effect of using the combined use of the Efferon CT device and HVHF on systemic hemodynamic parameters

  1-72 hours

• Effect of the combined use of the Efferon CT device and HVHF on pulmonary oxygen metabolism function

  1-72 hours

• Effect of the combined use of the Efferon CT device and HVHF on the indicators of the cardiac index

  1-72 hours

Study Arms (2)

Baseline therapy

NO INTERVENTION

Basic therapy - the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis

Basic therapy + Efferon CT + HVHF

EXPERIMENTAL

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).

Device: Efferon CT

Interventions

Efferon CT DEVICE

Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoperfusion. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa.

Basic therapy + Efferon CT + HVHF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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),

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

V.P. Demikhov City Clinical Hospital No. 68

Moscow, 109263, Russia

RECRUITING

MeSH Terms

Conditions

Infections; Pancreatitis; Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Makariy Mendibaev, MD

  Demikhov City Clinical Hospital of the Moscow Health Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be randomized stratified 1:1. The stratification criterion is the patient's SOFA index score.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 23, 2023
• Study Start: November 1, 2022
• Primary Completion: January 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

RU (1)