drugset / Trial / NCT07451886

Adjunctive Fludrocortisone in Septic Shock

NCT07451886

Phase 2 Recruiting 32 enrolled Chinese University of Hong Kong
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2026-04-01
Primary completion
2028-07-31
Completion
2028-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludrocortisone Other / unclassified 100 ug Other