跳至主要内容
临床试验/NCT05695001
NCT05695001已完成不适用

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

Efferon JSC1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Effect of Efferon CT hemoperfusion on SOFA scores (Sequential Organ Failure Assessment) in patients with acute pancreatitis.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Effect of Efferon hemoperfusion on interleukin levels (IL-1b, IL-6, IL-8, IL-10, IL-18)(1-72 hours)
  • The effect of Efferon CT hemoperfusion on length of stay in the intensive care unit(1-14 days)

研究者

发起方
Efferon JSC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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