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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 27, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07898462). This is a study registration, not published results. Lead sponsor: The George Institute. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 2200 participants (ESTIMATED). Conditions: Septic Shock. Interventions: DRUG: Fludrocortisone 50 mcg daily; DRUG: Fludrocortisone 100 mcg daily; DRUG: Placebo. Primary outcome measures: Days alive and free of organ support to day 28 , From randomisation through day 28 after randomisation.. Brief summary: The FLUDRO-SHOCK trial is a large international randomised controlled double-blinded study aiming to improve treatment for people with septic shock, a life-threatening condition caused by severe infection. Patients with septic shock receive a steroid called hydrocortisone, but it is unclear whether adding another steroid, fludrocortisone, improves their chances of recovery and survival. This study will test two doses of fludrocortisone (50 mcg and 100 mcg) against a placebo to see which works best. It will also explore whether a person's unique immune response, based on their genes, affects how well the treatment works. The trial will involve up to 2,200 critically ill adults in intensive care units across Australia and other countries. Researchers will track survival, organ recovery, and quality of life for up to a year. The goal is to find the most effective and personalised way to use steroids in septic shock, potentially saving lives and improving long-term outcomes.