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Acute Pancreatitis Without Necrosis or InfectionNCT05694988

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

A study testing Efferon CT in people with Acute Pancreatitis Without Necrosis or Infection, run by Efferon JSC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Efferon CT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteRussia
Study dates
1 Nov 2022to 3 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 22Show fewer
  • 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),
  • Unresolved biliary hypertension syndrome,
  • Acute thromboembolism of the pulmonary artery, confirmed by tomography,
  • Acute myocardial infarction within the last 4 weeks,
  • Acute cerebrovascular accident,
  • Transfusion reaction,
  • Severe congestive heart failure,
  • Uncontrolled bleeding (acute blood loss in the last 24 hours).

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • V.P. Demikhov City Clinical Hospital No. 68

    Moscow, 109263

Other trials in Russia

About this study

Official title: 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.

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.

Read more

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.

Read the detailed description

Acute pancreatitis in emergency surgery ranks third in frequency of its manifestation, second only to acute appendicitis and cholecystitis. The incidence of acute pancreatitis is growing from year to year and is more than 38 patients per 10,000 population per year. In 25% of patients, the development of pancreatitis is destructive.

Mortality in this pathology is mainly associated with the development of severe necrotic forms that cause a systemic inflammatory response of the body. The formation of pancreatic necrosis occurs within 1-2 days of illness, and it is at this time that the therapeutic effect is most effective.

Mortality in patients with acute pancreatitis reaches 20-60% depending on the nature of the disease, the phase of the pathological process, the severity of concomitant diseases, the severity of multiple organ failure syndrome (MODS), purulent-septic complications, and the development of septic shock. The main factors determining an unfavorable prognosis are the frequency of multiple organ failure and the development of sepsis, their intensity, as well as the developed septic shock. In the case of the onset and progression of multiple organ failure in the first 48 hours, they speak of early severe pancreatitis, which is characterized by a more unfavorable prognosis.

Acute pancreatitis is a systemic rather than a local critical condition. Associated complications include sepsis, multiple organ failure, ARDS, acute renal failure, disseminated intravascular coagulation syndrome, acute liver failure, etc. According to some reports, at least 50% of deaths in the early stage of acute pancreatitis are associated with multiple organ failure, and failure of three or more organs, mortality rises to 95%.

The moment when timely treatment can affect the outcome of the disease is often missed. Against the background of a picture of developed pancreatic necrosis, complications arise at lightning speed, despite the measures taken to prevent them.

The earliest possible detection of patients with an aggressive, destructive nature of the disease is very important for the entire complex of intensive care. The severity of the patient's condition with acute pancreatitis is largely determined by the severity of endotoxemia. The latter, in turn, depends on the cytokine response of the body.

To date, the early pathogenetic mechanisms of acute pancreatitis and its complications have not been sufficiently studied. The question of what happens at the subcellular level, what processes are responsible for the development of severe forms of the disease, extraorganic complications, remains insufficiently studied.

Treatment of acute pancreatitis is traditionally divided into conservative and surgical. The start time of conservative measures, their components, an adequate assessment of effectiveness affect the timing and extent of surgical intervention.

At the moment, there is no specific surgical approach for sterile and infected pancreatic necrosis. It is known that mortality from infected pancreatic necrosis is 2-3 times higher than from a sterile process.

"Cytokine storm", which occurs in the acute phase of pancreatitis, leads to aggravation of intoxication, inadequate and untimely correction of which underlies the development of pancreatogenic shock, multiple organ failure and septic complications.

Organ hypoperfusion, tissue hypoxia, endotoxicosis, systemic inflammatory and anti-inflammatory reactions induced by "mediator aggression" and electrolyte disturbances are the most important links in the etiopathogenesis of acute pancreatitis and multiple organ failure. Therefore, the use of detoxification methods aimed at removing toxic substances, normalizing organ perfusion, reducing systemic inflammation in the treatment of patients with acute pancreatitis is pathogenetically justified in order to prevent multiple organ failure, pancreatic shock and sepsis.

In the last 10 years, various methods of extracorporeal detoxification have become widespread in the practice of intensive care for severe forms of acute pancreatitis.

Nevertheless, there is no consensus among specialists regarding the timing of the application of certain methods, taking into account the phase course of acute pancreatitis, the required frequency of procedures and their effectiveness.

In acute pancreatitis, severe endotoxemia occurs early, leading to multiple organ failure. Allocate biochemical, immunological and microbial components of endogenous intoxication, which include intermediate and final metabolites of the processes of autolysis and secondary infection.

Detoxification underlies the prevention and pathogenetic treatment of complications of acute pancreatitis. Numerous studies have shown that the use of extracorporeal sorption methods that eliminate pro-inflammatory cytokines improves the results of treatment of patients with manifestations of endogenous intoxication.

Accumulated evidence in recent years suggests that continuous veno-venous hemofiltration is beneficial in acute pancreatitis by removing inflammatory molecules and medium and low molecular weight toxic substances by convection. Particular attention is paid to high-volume hemofiltration, which can give a better effect in the treatment of acute pancreatitis.

The 2012 study by La-Ping Chu (China) "Clinical effects of pulsed high-volume hemofiltration in severe acute pancreatitis complicated by multiple organ dysfunction syndrome" also confirmed that high-volume hemofiltration has a pronounced beneficial effect on clinical symptoms and laboratory parameters in acute pancreatitis with multiple organ failure .

In acute pancreatitis, a large number of soluble inflammatory mediators circulate in the patient's blood. Thus, the elimination of cytotoxins with standard continuous hemofiltration with a water exchange rate of 35 ml/kg/h may not be adequate for the severity of symptoms of the disease. The advantage of "high volume" is the removal of substances with a higher molecular weight, which include many inflammatory mediators. Numerous animal studies have shown a positive effect of high volume hemofiltration (HVHF) on survival in endotoxic models. Human studies have shown that HVHF improves hemodynamics in septic shock. But the great concern of researchers has always been the difficulty of performing high-volume hemofiltration as a continuous method. That is why it is of interest to study the effectiveness of short-pulse hemofiltration techniques in acute pancreatitis.

Recently, a search is underway for new approaches to the treatment of patients in the early stages of acute pancreatitis, even before the development of severe complications that significantly worsen the prognosis of the disease. One of them may be the extracorporeal removal of excessively produced inflammatory mediators (cytotoxins) from the systemic circulation by sorption. Nevertheless, very few studies have been devoted to the use of the hemosorption method in the early stage of acute pancreatitis, before the appearance of purulent-septic complications.

Hemosorption is a modern method of removing from the patient's blood substances that are toxic to body cells. Currently, there are no multicenter randomized studies confirming the need to use extracorporeal therapy methods as one of the main areas of pathogenetic therapy for acute pancreatitis. At the same time, there is more and more evidence of a significant effect of an increase in the level of cytokines on the pathogenesis of the disease and its progressive deterioration, which suggests a possible positive role of the cytokine hemosorption method performed in the early phase of acute pancreatitis.

In connection with the above data, it seems interesting to determine the degree of influence of the combined method of cytokine hemosorption (Efferon CT) and high-volume hemofiltration on the clinical manifestations of endogenous intoxication and organ dysfunction in acute pancreatitis. proceeding without septic complications.

Being tested
Efferon CT
Keywords
acute pancreatitis, sepsis, cytokines apsorbtion, hemoperfusion
Medical subject headings
Infections, Pancreatitis, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efferon CTDevice

    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.

Study groups in NCT05694988
Study groupRoleWhat they receive
Baseline therapyNo interventionBasic therapy - the routine practice of an institution for the treatment of patients with uninfected acute pancreatitis
Basic therapy + Efferon CT + HVHFExperimentalBasic 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).
Receives: Device: Efferon CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-72 hours

Secondary outcomes (3)
  1. Effect of using the combined use of the Efferon CT device and HVHF on systemic hemodynamic parameters

    Time (number of hours) from randomization to end of vasopressor support.

    Measured: 1-72 hours

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

    Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours.

    Measured: 1-72 hours

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

    Ultrasound assessment of LVOT VTI or RVOT VTI gain

    Measured: 1-72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start1 Nov 2022
  3. Primary completion31 Mar 2026
  4. Study completion3 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be randomized stratified 1:1. The stratification criterion is the patient's SOFA index score.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694988
Sponsor's protocol ID
efferon-ct-2022-03
Status last verified
Sep 2026
First submitted
13 Jan 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Efferon CT in people with Acute Pancreatitis Without Necrosis or Infection, run by Efferon JSC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of the combined use of the Efferon CT device and HVHF on indicators of organ dysfunction (time frame: 1-72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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