Adjunctive Fludrocortisone in Septic Shock

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Sepsis, Septic Shock, Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis and Septic Shock, Sepsis at Intensive Care Unit

In brief

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.

Key facts

Study ID

NCT07451886

Run by

Chinese University of Hong Kong

People needed

32

Starts

2026-04-01

Expected to finish

2028-07-31

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
• ≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
• onset of septic shock within 24 hours
• shock due to infection with no other proven or apparent cause
• hypoperfusion defined as arterial or venous lactate concentration >2.0 mmol/L
• mechanical ventilation

You may not qualify if…

• fludrocortisone cannot be administered within 24 hours of onset of septic shock
• death is deemed imminent or inevitable by treating clinicians
• limitation of therapy
• an underlying disease process with a life expectancy of less than 90 days
• pregnancy (confirmed or suspected)
• receiving immunomodulatory agents including hydrocortisone > 300mg/day
• enteral medication cannot be administered
• prescribed fludrocortisone for other medical condition
• contraindication to hydrocortisone or fludrocortisone

Where it is running

• Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)
• North District Hospital — Hong Kong, Hong Kong
• Pamela Youde Nethersole Hospital — Hong Kong, Hong Kong
• Princess Margaret Hospital — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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