Adjunctive Fludrocortisone in Septic Shock

Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone. To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.

NCT Number	NCT07451886
Lead Sponsor	Chinese University of Hong Kong
Conditions	Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
Enrollment	32 participants
Start Date	2026-04-01
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-02