NCT06225258 Xanthohumol as an Adjuvant in the Treatment of Septic Shock
| NCT ID | NCT06225258 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Lublin |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-01-09 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2023-01-09 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * lack of agreement * septic shock treated for more than 1 day, * history of severe chronic cardiac, pulmonary and/or liver diseases
Contact & Investigator
Wojciech Dabrowski, Prof
STUDY CHAIR
Medical University of Lublin, Poland
Frequently Asked Questions
Who can join the NCT06225258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06225258 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06225258 currently recruiting?
Yes, NCT06225258 is actively recruiting participants. Contact the research team at wojciech.dabrowski@umlub.pl for enrollment information.
Where is the NCT06225258 trial being conducted?
This trial is being conducted at Lublin, Poland.
Who is sponsoring the NCT06225258 clinical trial?
NCT06225258 is sponsored by Medical University of Lublin. The principal investigator is Wojciech Dabrowski, Prof at Medical University of Lublin, Poland. The trial plans to enroll 50 participants.