Xanthohumol as an Adjuvant in the Treatment of Septic Shock

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06225258
Study type	Interventional
Source	Medical University of Lublin
Contact	Wojciech Dabrowski, Prof
Phone	+48604241040
Email	wojciech.dabrowski@umlub.pl
Status	Recruiting
Phase	Phase 2
Start date	May 9, 2023
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Completed	`NCT05815264` - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above	Phase 1
Recruiting	`NCT04589936` - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care	N/A
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Completed	`NCT06210737` - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years	Phase 4
Terminated	`NCT03944551` - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa	N/A
Terminated	`NCT04660084` - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Withdrawn	`NCT05702788` - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)	Phase 2
Not yet recruiting	`NCT04171674` - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.	N/A
Active, not recruiting	`NCT03140163` - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]	N/A
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Recruiting	`NCT02515565` - Physiotherapy in Patients Hospitalized Due to Pneumonia.	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01446926` - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants	Phase 1
Completed	`NCT01416519` - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation	N/A
Completed	`NCT01399723` - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia	Phase 3
Completed	`NCT01416506` - Community-Acquired Pneumonia (CAP) Surveillance	N/A
Terminated	`NCT02358642` - Drug to Prevent Pneumonia in the Tube Fed	Phase 4