Pilot Study of Adding Fludrocortisone to Hydrocortisone Treatment in Adults with Septic Shock to Assess Feasibility of a Large International Trial

What this Trial Is About

Sepsis is a serious condition caused by the bodys uncontrolled response to infection, which can lead to septic shock, a life-threatening state. This research evaluates whether adding fludrocortisone to the standard treatment with hydrocortisone might improve outcomes for critically ill patients in shock. The study is a Phase II pilot trial designed to test the feasibility of a larger international study that would confirm if this combination therapy can reduce mortality in septic shock. The trial is a randomized, double-blind, placebo-controlled study conducted in six intensive care units across Hong Kong, Australia, and Singapore. Participants will receive either 100 mcg of enteral fludrocortisone daily or a placebo for up to seven days, alongside standard intravenous hydrocortisone given every six hours. The treatment period lasts until discharge from the ICU or death, whichever occurs first. Participants will be critically ill adults who have septic shock and require mechanical ventilation. Researchers will monitor protocol adherence, recruitment rates, time to shock resolution, mortality at 28 days, days free of organ support, and severe electrolyte imbalances. The study includes detailed tracking of feasibility outcomes, data completeness, and safety over approximately 20 months, with the aim of informing a larger future trial.

Adjunctive Fludrocortisone in Septic Shock