Consecutive Hemoperfusion and Therapeutic Plasma Exchange in Adult 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
- 82
- 试验地点
- 1
- 主要终点
- Shock - Free Days
研究概览
简要总结
Sepsis is a critical burden for a healthcare. From 2000 to 2020, the number of publications and clinical studies on the topic of Sepsis and septic shock on the National Library of Medicine resource The National Center for Biotechnology Information has tripled. Sepsis is a life-threatening condition that causes significant pathophysiological changes in the body. Currently, sepsis is understood as organ dysfunction caused by a dysregulatory response of the macroorganism to infection. A special role in this process belongs to the innate and adaptive immune response.
Despite the trend towards improving survival rates, mortality in sepsis remains high - about 25%, reaching 60% with the development of septic shock.
Extracorporeal therapy, as an adjuvant method of treatment, has been used for more than 30 years, but conducting large randomized studies confirming its effectiveness is associated with a complex of problems, including the extreme heterogeneity of the population of patients with sepsis and septic shock, different etiologies and complex pathogenesis, non-identical pathophysiological pathways of the dominant organ dysfunction in specific time period and degree of its severity.
Goal of the study is to evaluate safety and efficiency of combined hemoperfusion and therapeutic plasma exchange in adult patients with septic shock.
详细描述
Sepsis is a critical burden for a healthcare. From 2000 to 2020, the number of publications and clinical studies on the topic of Sepsis and septic shock on the National Library of Medicine resource The National Center for Biotechnology Information has tripled. Sepsis is a life-threatening condition that causes significant pathophysiological changes in the body. Currently, sepsis is understood as organ dysfunction caused by a dysregulatory response of the macroorganism to infection. A special role in this process belongs to the innate and adaptive immune response.
Despite the trend towards improving survival rates, mortality in sepsis remains high - about 25%, reaching 60% with the development of septic shock.
Modern understanding of the pathophysiology of sepsis allows us to identify several groups of molecules that are of significant interest as targets for targeted therapy. Activation of Toll-like receptors of neurophils and macrophages by the so-called PAMPs (pathogen-associated molecular patterns) - extracellular bacterial DNA, lipopolysaccharides, flagellin, lipoteichoic acid, peptidoglycan) leads to changes in the transcription of genes involved in the regulation of the inflammatory response, cellular metabolism with a significant release of cytokinessuch as IL-1, TNF-α, IL-2, IL-6, IL-8, IL-10, IFN-γ and complement proteins.
Extracorporeal therapy, as an adjuvant method of treatment, has been used for more than 30 years, but conducting large randomized studies confirming its effectiveness is associated with a complex of problems, including the extreme heterogeneity of the population of patients with sepsis and septic shock, different etiologies and complex pathogenesis, non-identical pathophysiological pathways of the dominant organ dysfunction in specific time period and degree of its severity.
The strategy of using separate methods for extracorporeal elimination of LPS and cytokines yielded controversial results, with an obvious association of endotoxemia and high concentrations of inflammatory mediators with mortality and severity of organ failure.
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
- 否
入选标准
- •Age over 18 years
- •Sepsis (SEPSIS-3)
- •No more than 24 hours from the onset of septic shock.
- •Septic shock, defined as hypotension in sepsis:
- •Persisting after infusion therapy in a volume of 30 ml/kg
- •Requiring sympathomimetic therapy with one or more of the listed drugs with the indicated doses: norepinephrine - more than 0,05 mcg/kg/min, dopamine - more than 10 mcg/kg/min, adrenaline - more than 0,05 mcg/kg/min,
排除标准
- •Inability to achieve and maintain mean arterial pressure more than 65 mm Hg
- •History of transfusion reactions, TRALI
- •Allergy to heparin, history of HIT
- •Uncontrolled bleeding or a high risk of its occurrence
- •The presence of cardiovascular events during the last 2 months: AMI, stroke, pulmonary embolism
- •Severe congestive CHF
- •Terminal CKD, PGD
- •HIV infection
- •Continuous immunosuppressive therapy
- •Severe granulocytopenia (WBC less than 500 cells/mm3)
结局指标
主要结局
Shock - Free Days
时间窗: 0-7 days
All days of life, without vasopressor or inotropic support. A patient is given a value of 0 if they die before day 7 or are still remains in shock at day 7.
次要结局
- ICU - Free Days(0-60 days)
- Mechanical ventilation - Free Days(0-60 days)
- Change SOFA score(0-48 hours)
- Change oxygenation index(0-48 hours)