A Multicenter Prospective Observational Study With a Control Group to Evaluate the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With SepSis (LASSO NEO).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 14
- 主要终点
- Effect of Efferon LPS NEO Hemoperfusion on pSOFA (pediatric Sequential Organ Failure Assessment) Scores in Patients with Sepsis
研究概览
简要总结
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. The decrease in the sensitivity of bacterial pathogens to antibiotics, the widespread use of invasive diagnostic and treatment methods, the increased role of opportunistic microorganisms and fungi, and the increase in the number of people with severe chronic diseases led to an increase in the incidence of sepsis in the period from 1979 to 1979. 2000 by 8.7% per annum.
Sepsis is one of the leading causes of hospital mortality in children. Multicenter cross-country studies of pediatric sepsis using a prospective methodology in nearly 7,000 children (mean age 3 years) in 128 pediatric intensive care units (ICUs) in 26 different countries showed that a typical 16-bed intensive care unit should have, on average, at least one child with sepsis.
Sepsis and septic shock in most cases are accompanied by the development of multiple organ failure syndrome (MODS). The frequency of adverse outcomes directly depends on the number of organ systems involved in MODS: it increases from 6% in patients with dysfunction of one organ at the time of admission to the intensive care unit to 65% in patients with organ failure of 4 systems or more. Despite modern advances in resuscitation and antimicrobial chemotherapy, if the etiological agent of sepsis is gram-negative flora, mortality can reach 75%.
Numerous studies have shown that the use of extracorporeal sorption methods that eliminate endotoxin improves the results of treatment of patients with septic shock. The use of LPS selective adsorption is both an etiological and pathogenetic method of treatment, which justifies the need for its use in the complex intensive care of sepsis and septic shock.
The method of hemosorption technology using a cartridge based on a mesoporous supercrosslinked copolymer of styrenedivinylbenzene with an LPS-selective ligand immobilized on the surface, which has the ability to neutralize the biological activity of endotoxin by binding lipid A, the main pathogenic site of LPS. the molecule matters.
The main goal of the study was to obtain data on the efficacy and safety of using the Efferon LPS NEO hemosorption column for the adsorption of lipopolysaccharides during extracorporeal detoxification in children aged 1 month to 14 years with sepsis.
详细描述
One of the major health problems in the world is sepsis, the number of cases of which, according to WHO, annually reaches 20-30 million. Decreased sensitivity of bacterial pathogens to antibiotics, widespread use of invasive methods of diagnosis and treatment, increased role of opportunistic microorganisms and fungi, increased the number of people with severe chronic diseases led to an increase in the incidence of sepsis in the period from 1979 to 2000 by 8.7% annually.
Sepsis is one of the leading causes of hospital mortality in children. Multicenter studies in pediatric sepsis in various countries using a prospective methodology in nearly 7,000 children (mean age 3 years) in 128 pediatric intensive care units (ICUs) in 26 different countries showed that in a typical 16-bed PICU, on average there must be at least one child with sepsis.
In the United States, 75 thousand cases of sepsis in children are recorded annually, and the mortality rate for severe sepsis is 21%. Importantly, nearly 25% of sepsis survivors had a clinically significant health-related deterioration in quality of life, with one in three survivors being discharged with a disability (24% of previously healthy children were discharged with some form of disability).
In a recent systematic review and meta-analysis of the epidemiology of sepsis, the incidence of sepsis in children was 48 cases per 100,000 people per year, and septic shock was 22 cases per 100,000 people per year. In general, the authors determined the incidence of 1.2 million cases of sepsis in children per year. Mortality in children with septic shock ranged from 9 to 20%. Significantly, this systematic review did not include studies from low-income countries where morbidity and mortality from sepsis in children is likely to be higher.
Sepsis and septic shock in most cases are accompanied by the development of multiple organ failure syndrome (MODS). The frequency of adverse outcomes directly depends on the number of organ systems involved in MODS: increasing from 6% in patients with dysfunction of one organ at the time of admission to the ICU to 65% in patients with organ failure of 4 systems or more. Also, lethality is largely determined by the etiology of this complication. Despite modern advances in antimicrobial chemotherapy, if the etiological agent of sepsis is gram-negative flora, mortality can reach 75% and the overall prognosis of patients with endotoxemia and septic shock remains extremely poor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight from 5 kg. up to 40 kg (main criterion),
- •Age from 1 month to 14 years,
- •No more than 12 hours from the moment of establishment of DZ - Sepsis in accordance with the criteria of SEPSIS-3 (2016, modified for childhood), most likely, Gr-etiology, at the time of inclusion.
- •The immediate postoperative period in case of abdominal nature of sepsis (no more than 12 hours after surgery),
- •If the patient has a focus of surgical infection, then it should be sanitized,
- •pSOFA scale ≥ 6 points, or an increase in negative dynamics on the pSOFA scale by 2 or more points over 12 hours of observation,
- •The patient's condition allows for therapy with the Efferon LPS NEO column for at least 4 hours.
排除标准
- •Weight below 5 kg and over 40 kg,
- •Age less than 1 month and over 14 years old,
- •Failure to obtain informed consent from the patient's parents, family member or legal representative,
- •The presence of a focus of non-sanitized surgical infection,
- •Use in the treatment of other methods of extracorporeal removal of LPS and inflammatory mediators (hemofilters with highly permeable and surface-modified membranes),
- •Acute pulmonary embolism,
- •Intracranial hemorrhage or bleeding tendency in general,
- •Induced aplasia of hematopoiesis,
- •If it is impossible to provide vascular access necessary for the method,
- •Any other condition that, in the opinion of the Investigator, would prevent the patient from being a suitable candidate for inclusion in the trial (for example, a chronic disease in the terminal stage or a mental disorder that affects the methodology for conducting a hemoperfusion procedure, as well as for patients who have a "palliative status ").
结局指标
主要结局
Effect of Efferon LPS NEO Hemoperfusion on pSOFA (pediatric Sequential Organ Failure Assessment) Scores in Patients with Sepsis
时间窗: 1-7 days
The value of indicators on the pSOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (0 hour) to 7 days. The pSOFA score was developed using validated age-adjusted cut points for the cardiovascular and renal criteria from the second Pediatric Logistic Organ Dysfunction (PELOD-2) scoring system. Scores were calculated daily from admission to the PICU until day 7 of stay, discharge, or death, whichever came first.The pSOFA 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. The lower the pSOFA index, the less pronounced organ failure and the better the patient's survival prognosis.
次要结局
- Effect of Efferon LPS NEO hemoperfusion on systemic hemodynamic parameters after initiation of use in patients with sepsis complicated by septic shock(1-72 hours)
- Influence of hemoperfusion Efferon LPS NEO in extracorporeal therapy of patients with complicated sepsis septic shock(1-14 days)
- Effect of the Efferon LPS NEO hemoperfusion on the length of stay in the PICU(1-14 days)
- Effect of LPS NEO Efferon hemoperfusion on endotoxin activity(1-72 hours)
- Effect of the Efferon LPS NEO hemoperfusion on pulmonary oxygen metabolism function(1-72 hours)