Acute Pancreatitis With Uninfected Necrosis, UnspecifiedNCT05695001
Hemoperfusion Efferon СT for the Treatment of Patients With Acute Pancreatitis
An observational study of Acute Pancreatitis With Uninfected Necrosis, Unspecified, run by Efferon JSC at 1 site in Russia.
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 years and older
- Conditions the study is for
- Acute Pancreatitis With Uninfected Necrosis, Unspecified
- What is being tested?
- Efferon CT
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2022to 30 Nov 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Observational Prospective Pilot Study of the Efficacy and Safety of Cytokine Hemosorption Using the Efferon CT Device in Acute Endogenous Intoxication in Patients With Acute Pancreatitis and Aseptic Pancreatic Necrosis
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.
Read more
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.
Read the detailed description
Acute pancreatitis in emergency surgery takes the 3rd place in terms of the 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. Quite often, upon admission of a patient, the severity of his condition, the data of laboratory and instrumental methods of examination do not allow us to judge the further course of the disease.
The existing systems and scales for assessing the severity of the patient APACHE II, SAPS, MODS, SOFA, Glasgow, J. Ranson and others provide an acceptable accuracy of about 80% only after 48 hours from the onset of the disease, and before that time they are of little information. This means that the severity of the condition of 20% of patients with necrotizing pancreatitis cannot be assessed in time by these systems until its clinical deterioration is obvious. Thus, often, the time when adequate treatment can affect the outcome of the disease is missed. After that, against the background of the picture of pancreatic necrosis, complications arise at lightning speed and like an avalanche, despite the measures taken to prevent them.
In this regard, the earliest identification of patients with an aggressive, destructive nature of the disease for the entire complex of intensive care seems to be very important. 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. "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.
To date, the early pathogenetic mechanisms of acute pancreatitis and its complications are poorly understood. 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 tactics for sterile and infected pancreatic necrosis, as well as for its purulent-septic complications. It is known that lethality from infected pancreatic necrosis is 2-3 times higher than from a sterile process.
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.
In connection with the increasing spread of the "cytokine theory" in the past 10 years, various methods of extracorporeal detoxification have become widespread in the practice of intensive care for severe forms of acute pancreatitis. Despite this, there is no consensus among specialists regarding the timing of the application of certain techniques in the context of the phase course of acute pancreatitis, the required frequency of procedures, and their effectiveness.
In acute pancreatitis, severe endotoxemia occurs early, which leads to the development of 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 tests have shown that the use of extracorporeal sorption methods, the eliminirinducing pro-inflammatory cytokines, improves the results of treatment of patients with manifestations of endogenous intoxication.
Many techniques have been described - hemofiltration (HF), enterosorption, ultrahemofiltration (UHF), hemosorption (HS), plasmapheresis (PF). Very few studies have been devoted to the use of the hemosorption method in the early stage of development of acute pancreatitis, before the appearance of septic complications.
Recently, there has been a search for new approaches to the treatment of patients in the early stages of pancreatitis, even before the development of formidable complications, significantly worsening the prognosis of the disease. One of them may be extracorporeal removal from the systemic circulation of excessively produced mediators of the inflammatory response (cytokines) by hemosorption.
Hemosorption is the most modern method of removing substances toxic to body cells from the patient's blood. The procedure is carried out outside the body by pumping the blood flow through a column filled with a sorbent (hemoperfusion procedure). Critical parameters for therapeutic efficacy are the type of sorbent, its volume, the number of repeated procedures; they are individualized depending on the identified pathological disorders and the patient's condition.
Currently, there are no multicenter randomized studies confirming the need for extracorporeal blood purification methods as one of the main areas of pathogenetic therapy for acute pancreatitis. At the same time, the increasing emergence of data on the significant influence of the "cytokine storm" on the pathogenesis of the disease and its progressive deterioration suggests a possible positive role of the cytokine hemosorption method performed in the early phase of acute pancreatitis.
Efferon CT (JSC Efferon, Moscow, Russia) is a device for extracorporeal blood purification using 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.
In connection with the above data, the purpose of this clinical study is to determine the degree of influence of the use of the hemosorption device Efferon CT (JSC Efferon, Russia) on the clinical manifestations and laboratory parameters of acute pancreatitis occurring without septic complications.
- Being tested
- Efferon CT
- Keywords
- acute pancreatitis, sepsis, cytokine sorption, endogenous intoxication
- Medical subject headings
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Efferon CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-72 hours
Secondary outcomes (2)
The effect of Efferon CT hemoperfusion on length of stay in the intensive care unit
Time (number of days) from enrollment in the study to transfer from the intensive care unit within 14 days.
Measured: 1-14 days
Effect of Efferon hemoperfusion on interleukin levels (IL-1b, IL-6, IL-8, IL-10, IL-18)
The significance of interleukin levels before the start of hemoperfusion and 72 hours after the start of hemoperfusion
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.
- First posted23 Jan 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis With Uninfected Necrosis, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Kiselev, PhD, MD, Principal investigator, N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695001
- Sponsor's protocol ID
- efferon-ct-2022-02
- Status last verified
- Feb 2024
- First submitted
- 13 Jan 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Observational Prospective Pilot Study of the Efficacy and Safety of Cytokine Hemosorption Using the Efferon CT Device in Acute Endogenous Intoxication in Patients With Acute Pancreatitis and Aseptic Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT05695001
- Acronym / sponsor ID
- efferon-ct-2022-02
- Keywords
- acute pancreatitis, sepsis, cytokine sorption, endogenous intoxication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute pancreatitis in emergency surgery takes the 3rd place in terms of the 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. Quite often, upon admission of a patient, the severity of his condition, the data of laboratory and instrumental methods of examination do not allow us to judge the further course of the disease.
The existing systems and scales for assessing the severity of the patient APACHE II, SAPS, MODS, SOFA, Glasgow, J. Ranson and others provide an acceptable accuracy of about 80% only after 48 hours from the onset of the disease, and before that time they are of little information. This means that the severity of the condition of 20% of patients with necrotizing pancreatitis cannot be assessed in time by these systems until its clinical deterioration is obvious. Thus, often, the time when adequate treatment can affect the outcome of the disease is missed. After that, against the background of the picture of pancreatic necrosis, complications arise at lightning speed and like an avalanche, despite the measures taken to prevent them.
In this regard, the earliest identification of patients with an aggressive, destructive nature of the disease for the entire complex of intensive care seems to be very important. 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. "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.
To date, the early pathogenetic mechanisms of acute pancreatitis and its complications are poorly understood. 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 tactics for sterile and infected pancreatic necrosis, as well as for its purulent-septic complications. It is known that lethality from infected pancreatic necrosis is 2-3 times higher than from a sterile process.
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.
In connection with the increasing spread of the "cytokine theory" in the past 10 years, various methods of extracorporeal detoxification have become widespread in the practice of intensive care for severe forms of acute pancreatitis. Despite this, there is no consensus among specialists regarding the timing of the application of certain techniques in the context of the phase course of acute pancreatitis, the required frequency of procedures, and their effectiveness.
In acute pancreatitis, severe endotoxemia occurs early, which leads to the development of 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 tests have shown that the use of extracorporeal sorption methods, the eliminirinducing pro-inflammatory cytokines, improves the results of treatment of patients with manifestations of endogenous intoxication.
Many techniques have been described - hemofiltration (HF), enterosorption, ultrahemofiltration (UHF), hemosorption (HS), plasmapheresis (PF). Very few studies have been devoted to the use of the hemosorption method in the early stage of development of acute pancreatitis, before the appearance of septic complications.
Recently, there has been a search for new approaches to the treatment of patients in the early stages of pancreatitis, even before the development of formidable complications, significantly worsening the prognosis of the disease. One of them may be extracorporeal removal from the systemic circulation of excessively produced mediators of the inflammatory response (cytokines) by hemosorption.
Hemosorption is the most modern method of removing substances toxic to body cells from the patient's blood. The procedure is carried out outside the body by pumping the blood flow through a column filled with a sorbent (hemoperfusion procedure). Critical parameters for therapeutic efficacy are the type of sorbent, its volume, the number of repeated procedures; they are individualized depending on the identified pathological disorders and the patient's condition.
Currently, there are no multicenter randomized studies confirming the need for extracorporeal blood purification methods as one of the main areas of pathogenetic therapy for acute pancreatitis. At the same time, the increasing emergence of data on the significant influence of the "cytokine storm" on the pathogenesis of the disease and its progressive deterioration suggests a possible positive role of the cytokine hemosorption method performed in the early phase of acute pancreatitis.
Efferon CT (JSC Efferon, Moscow, Russia) is a device for extracorporeal blood purification using 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.
In connection with the above data, the purpose of this clinical study is to determine the degree of influence of the use of the hemosorption device Efferon CT (JSC Efferon, Russia) on the clinical manifestations and laboratory parameters of acute pancreatitis occurring without septic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Efferon CTBasic therapy is a routine practice of the institution for the treatment of patients with acute uninfected pancreatitis in combination with extracorporeal hemoperfusion (Efferon CT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon CTEfferon 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. | Device | Experimental: Basic therapy + Efferon CT |
Primary outcome
Effect of Efferon CT hemoperfusion on SOFA scores (Sequential Organ Failure Assessment) in patients with acute pancreatitis.
Time frame: 1-72 hours
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.
2 secondary outcomes
The effect of Efferon CT hemoperfusion on length of stay in the intensive care unit
Time frame: 1-14 days
Effect of Efferon hemoperfusion on interleukin levels (IL-1b, IL-6, IL-8, IL-10, IL-18)
Time frame: 1-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Kiselev, PhD, MD principal investigator
N. V. Sklifosovsky Moscow Research Institute of Emergency, Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis With Uninfected Necrosis, Unspecified, 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 4 inclusion and 12 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 21 Feb 2024. 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 Efferon CT hemoperfusion on SOFA scores (Sequential Organ Failure Assessment) in patients with acute pancreatitis. (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 21 Feb 2024.