Early Efferon LPS Hemoperfusion Through Hypercrosslinked Styrene-divinylbenzene Copolymer With Immobilized LPS-selective Ligand for Treatment of Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Effect of Efferon LPS hemoperfusion on vasopressor dose after initiation of use in patients with abdominal sepsis complicated by septic shock.
研究概览
简要总结
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate endotoxin and\or excess of cytokines improve treatment outcomes in patients with septic shock. Aim of the study: to evaluate safety and feasibility of clinical use of an extracorporeal blood adsorber based on a hypercrosslinked styrene-divinylbenzene copolymer with immobilized lipopolysaccharide (LPS)-selective ligand designed to remove endotoxins from the bloodstream to treat patients with septic shock.
详细描述
Introduction. Sepsis, according to the latest consensus definition (SEPSIS-3, 2016), is a disease characterized by life-threatening organ failure resulting from a disordered regulation of the body's response to infection. Sepsis continues to be the leading cause of death in intensive care units in almost any country in the world.
The highest mortality rate in sepsis is associated with the development of septic shock (SS). Septic shock is defined as sepsis (according to the criteria of SEPSIS-3, 2016) accompanied by severe hemodynamic, cellular and metabolic disorders, with a higher risk of fatal outcome than sepsis without shock. On average, SS is detected with a frequency of 8.3-10.4% among ICU patients, and its mortality, according to recent estimates, reaches 38-50% and even higher, exceeding 50-80% with such comorbidity as diabetes mellitus.
Success in treating septic shock is traditionally associated with adequate vasopressor, antibacterial, and anti-shock therapy, including inotropic support. At the same time, such factors as multiple antibiotic resistance of Gram-negative bacteria, changes in the intestinal microbiota and associated profile of bacterial metabolites entering circulation and participating in the pathogenesis of sepsis, other bacterial products such as pathogen-associated molecular patterns and cytokines induced by them, bacterial endotoxins contributing most to the multiorgan failure, nowadays are considered as new targets for developing effective mtools of controlling the septic shock sequelae.
Taking into account the key role of bacterial endotoxins in the pathogenesis of septic shock and the absence of a significant trend for reducing mortality in response to the medication treatment, increasing interest is being focused on extracorporeal methods of clearing the endotoxins and inflammatory immune mediators from the bloodstream. Such methods are designed to reduce the levels of pathogenetically significant molecules in the systemic circulation down to less critical values at least for a certain period of time in order to enable the immune system and antibiotics to reduce the bacterial load and the production of new endotoxin molecules.
The methods used and developed with respect to selective adsorption of endotoxin molecules from the bloodstream are promising. They provide, at early stages of the disease, interruption of the pro-inflammatory cascade initiated by inborn immune cells and causing organ dysfunction. At the same time, the place of LPS-selective hemoperfusion in sepsis therapy is still not clearly defined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gram-negative agents in the blood; or detection of an infection focus suggesting Gram-negative agents; or suspected infection based on patient condition, presence of at least two criteria for a systemic inflammatory response and procalcitonin (PCT) level ≥ 2 ng/ml;
- •severity of organ dysfunction assessed on a Sepsis-related Organ Failure Assessment (SOFA) scale > 4 points as a result of an evident or suspected infection;
- •need for vasopressor support after administration of fluids to maintain an average blood pressure of at least 65 mmHg. and lactate level in serum > 2 mmol/l (optional, for diagnosis of septic shock).
- •An additional criterion was the endotoxin activity exceeding 0.6 units according to EAA
排除标准
- •terminal condition,
- •ongoing internal bleeding or high risk of bleeding,
- •severe heart failure (left ventricular ejection fraction < 25%),
- •decompensated liver failure,
- •body weight less than 20 kg,
- •age < 18 or > 80 years.
结局指标
主要结局
Effect of Efferon LPS hemoperfusion on vasopressor dose after initiation of use in patients with abdominal sepsis complicated by septic shock.
时间窗: 1-120 hours
The time (number of hours) from inclusion in the study to the earliest time that the 'resolution of septic shock' event is achieved. Event criteria is end of vasopressor support (persistence of effect - for 4 hours).
次要结局
- Effect of LPS Efferon hemoperfusion on procalcitonin levels in patients with abdominal sepsis complicated by septic shock.(1-120 hours)
- Effect of LPS Efferon hemoperfusion on SOFA scores in patients with abdominal sepsis complicated by septic shock.(1-120 hours)
- Effect of LPS Efferon hemoperfusion on endotoxin activity in patients with abdominal sepsis complicated by septic shock.(1-72 hours)
- Effect of LPS Efferon hemoperfusion on IL-1β levels in patients with abdominal sepsis complicated by septic shock.(1-24 hours)
- Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function in patients with abdominal sepsis complicated by septic shock(1-120 hours)