A Phase 2 interventional study of Xanthohumol in Septic Shock, Pneumonia and ARDS, sponsored by Medical University of Lublin. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by Medical University of Lublin · Phase 2, Interventional, and Treatment
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 50 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Medical University of Lublin is the lead sponsor of 62 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Patients are treated according to the recommendations of the Surviving Sepsis Campaign.
Patients, who are admitted to the Intensive Care Unit (ICU) due to septic shock in the early, acute phase. Patients are treated according to the recommendations of the Surviving Sepsis Campaign and receive xanthohumol at a dose of 2 mg per kg body weight administered via nasogastric tube as supportive therapy.
Dietary Supplement: Xanthohumol
Patients, who received Xanthohumol (Chmiel-Xn-Active, SALUTIS Pharmacy, Poland) as adjunctive therapy to treatment recommended by Surviving Sepsis Campaign. Xanthohumol is administrated by the nosogastric tube three times a day \*every 8 hours) at the dose of 2 mg.\\/kg body weight for 10 days. The first dose of Xanthohumol is administrated within 4 hours after the admission to the ICU.
Also known as: ChmielXnActive (Salutis Pharmacy, Poland)
Xanthohumol as an adjunctive treatment improves clinical course in ill septic shock patents
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.
Time frame: 7 and 28 days mortality
Xanthohumol as an adjunctive treatmenty affects a severity of inflammation
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.
Time frame: 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 sepsis-related glycocalyx injury
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.
Time frame: 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.
Interleukin 1beta, also known as lymphocyte activating factor, is produced and released by activated macrophages and monocytes and is important biomarker of inflammatory response. Its elevated concentrations relate to severity of inflammation, while its reduction corresponds to effective treatment. Rapid decrease in the circulating interleukin 1beta concentration may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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.
Tumor necrosis factor-alpha (TNF-alpha) is a pro-inflammatory cytokine released by different cells including macrophages, endothelial cells, lymphoid cells and others to stimulate the immune system into an inflammatory response. It is released as a response to lipopolysaccharide or other bacterial products following infection. A high concentration of TNF-alpha corresponds to the severity of inflammatory response and endothelial hyper-permeability with glycocalyx damage. Rapid decrease in the circulating TNF-alpha concentration may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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.
Interleukin 6 is the most recognized pro-inflammatory cytokine. It is also anty-inflammatory myokine. Interleukine 6 is released by macrophages in response to microbial molecules such as pathogen-associated molecular patterns or damage-associated molecular patterns. Interleukin 6 is an important mediator of fever and of the acute phase of inflammatory response. A rapid decrease in the circulating interleukin 6 concentration may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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.
Interleukin 8 is a chemokine produced by different cells including macrophages and epithelial cells. It is a mediator associated with inflammation and plays a crucial role in neutrophil recruitment and neutrophil degranulation. Interleukin 8 is secreted as a response to oxidant stress. It correlates with endothelial injury. Its rapid decrease in the circulating blood may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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
Interleukin 17 is a pro-inflammatory cytokine that is produced by a group of T helper cells known as T helper 17 cells in response to their stimulation with interleukin 23. Its elevated concentrations correspond to the severity of inflammation, while its reduction corresponds to effective treatment. A decrease in its concentration in the circulating blood may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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.
Interleukin 23 is an inflammatory cytokine secreted by activated dendric cells, macrophages, or monocytes. IL-23 is also produced by B cells through B cell antigen receptor signaling. Polarisation to a Th17 phenotype is triggered by interleukin-6. Rapid decrease in the circulating IL-23 concentration may reflect changes in IL-17 concentration that confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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
Interleukin 40 is synthetized by C17orf99 and activated B cells after being stimulated with anti-CD40 monoclonal antibodies. It is a key effector in the humoral immune system. IL-40 exerts proinflammatory effects. Decrease in IL-40 may confirm the efficacy of Xanthohumol in critically ill patients treated for septic shock. 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.
Time frame: 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.
Syndecan-1 is a heparan sulfate proteoglycan expressed in endothelial cells and is a well-known marker of endothelial glycocalyx degradation. Its elevated plasma concentration corresponds to endothelial injury and was noted in septic shock patients. A decrease in the inflammatory response following Xanthohumol administration reduces the severity of glycocalyx damage and endothelial injury. 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.
Time frame: 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.
Vascular endothelial adhesion molecule 1 is a protein expressed in endothelial cells in response to pro-inflammatory cytokines including interleukine1 and tumor necrosis factor-alpha or bacterial endotoxin. Its elevated plasma concentration correlates with disorders in vascular permeability and documents endothelial damage following inflammation. A decrease in the severity of inflammation and the amount of circulating pro-inflammatory cytokines can reduce the severity of endothelial injury reflected by a decrease in plasma vascular endothelial adhesion molecule 1 concentration. 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.
Time frame: 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.
E-selectin is a glycoprotein expressed on endothelial cells after activation by interleukin 1beta, tumor necrosis factor-alpha, or bacterial lipopolysaccharides. Its expression is crucial to control leukocyte accumulation in inflammatory responses. Elevated plasma E-selectin concentration was documented in sepsis and patients treated for inflammatory diseases without septic syndromes. Plasma E-selectin concentration correlates with the severity of inflammation and endothelial damage. A decrease in the severity of inflammation and the amount of circulating pro-inflammatory cytokines can reduce the severity of endothelial injury reflected by a decrease in plasma vascular endothelial adhesion molecule 1 concentration. 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.
Time frame: 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.
Vascular endothelial growth factor (VEGF) is a protein, which is considered as a sensitive marker of endothelial damage and vascular permeability. It is originally known as vascular permeability factor. VEGF-A production can be induced in the endothelial cells by circulating cytokines and severe hypoxia. A decrease in the severity of inflammation and the amount of circulating pro-inflammatory cytokines can reduce the severity of endothelial injury reflected by a decrease in VEGF-A concentration. 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.
Time frame: 7 time points: just after ICU admission and on the days 1,2,3,4,5 and 6 after ICU admission.
Started Jan 2023 (actual). Primary completion is estimated for Oct 2025, 33 months after the start.
Of 36 non-industry phase 2 interventional studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 33 months is above that.
Counting every sponsor, half of 41 studies reached it within 29 months; a quarter within 15 and three quarters within 42.
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Studies of the drug tested here: Xanthohumol
Medical University of Lublin