Analysis of Anti-inflammatory Effect of Hop Extract Rich in Xanthohumol in Patients Treated for Septic Shock
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Xanthohumol as an adjunctive treatment improves clinical course in ill septic shock patents
研究概览
简要总结
Septic shock (SS) is a life-threatening condition resulting from excessive inflammatory response to bacterial, viral or/and fungal infections. It is associated with dysregulation of the immune system, activation of immune cells, and massive release of cytokines, commonly known as the cytokine storm (CS). The clinical manifestations of SS depend on the initial site of infection. However, the classic symptoms are associated with severe dysfunction of the respiratory and cardiovascular systems, which are observed from the early phase. Respiratory insufficiency frequently requires different forms of oxygen supplementation, including mechanical ventilation and even extracorporeal oxygenation. The severity of respiratory and other organ dysfunction depends on the inflammatory response to the infection and circulating toxins, which correspond to excessive cytokine release. In the past years, several studies documented that reduction of SS-related inflammatory response and CS improved organ function and alleviated the clinical course of SS. Unfortunately, an effective strong anti-inflammatory without side effects medications has not yet been found. Therefore, the use of natural anti-inflammatory and antioxidant substances seems very promising.
Xanthohumol (Xn) is a natural prenylated chalcone extracted from the female inflorescences of hop cones (Humulus lupus) and possesses strong anti-inflammatory and antioxidant properties. It is widely used as a supplement to diet. Xanthohumol inhibits CS and has been showed to be an effective medication for reducing the severity of lung injury. It has been documented that Xn inhibits proinflammatory pathways in a different manner. A decrease in cytokine production and release can affect endothelial function and correct inflammatory-related vascular hyperpermeability, reducing uncontrolled water shift to extravascular space and then tissue edema. Clinical observation showed that administration of Xn alleviated clinical course, improved respiratory function, and reduced mortality in critically ill COVID-19 patients. Xanthohumol is safe and well tolerated by humans, and no adverse effects have been reported yet. Based on its strong anti-inflammatory and antioxidative properties, it can be speculated that the use of Xn can effectively reduce the inflammatory response and improve the clinical course in SS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •a septic shock in the early, acute phase,
- •respiratory insufficiency required mechanical ventilation with PaO2/FiO2 < 150,
- •bacterial infection,
- •procalcitonin higher than 5 ng/mL and interleukin 6 higher than 100 pg/mL,
- •no allergy to hops or their derivatives,
- •hemodynamic instability requiring vasopressor infusions
排除标准
- •lack of agreement
- •septic shock treated for more than 1 day,
- •history of severe chronic cardiac, pulmonary and/or liver diseases
结局指标
主要结局
Xanthohumol as an adjunctive treatment improves clinical course in ill septic shock patents
时间窗: 7 and 28 days mortality
Xanthohumol as an adjunctive treatment can significantly reduce mortality and length of hospitalization in critically ill patients. This effect can be reflected by analysis of the mortality rate on days 7 and 28 after the admission to the ICU.
Xanthohumol as an adjunctive treatment affects sepsis-related glycocalyx injury
时间窗: 7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.
The use of xanthohumol as adjunctive treatment can reduce septic-induced glycocalyx injury. The severity of glycocalyx damage can be measured by changes in plasma biomarker concentrations, which are typical of glycocalyx damage. Blood samples are collected from arterial access at nine time points: just after ICU admission (baseline) and in the morning on days 1, 2, 3, 4, 5, and 6 after ICU admission.
Xanthohumol as an adjunctive treatmenty affects a severity of inflammation
时间窗: 7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.
The use of xanthohumol as adjunctive treatment can reduce the inflammatory response in the acute early phase of septic shock. Plasma concentrations of pro-inflammatory cytokines can reflect this effect. Blood samples are collected from arterial access at nine time points: just after ICU admission (baseline) and in the morning on days 1, 2, 3, 4, 5, and 6 after ICU admission.
次要结局
- Xanthohumol as an adjunctive treatment affects plasma interleukin 1beta concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment changes plasma tumor necrosis factor-alpha concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 6 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 8 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 17 concentration(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma syndecan 1 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 23 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 40 concentration(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma vascular endothelial adhesion molecule 1 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma E-selectin concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma vascular endothelial growth factor concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 1beta concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment changes plasma tumor necrosis factor-alpha concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 6 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma interleukin 8 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma syndecan 1 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma vascular endothelial adhesion molecule 1 concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma E-selectin concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)
- Xanthohumol as an adjunctive treatment affects plasma vascular endothelial growth factor concentration.(7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.)