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Factsheet

Background

  • Septic shock is a life‑threatening condition with high mortality, highlighting a critical need for more effective treatments.
  • Although corticosteroids have been used for decades, the optimal approach to adjunctive fludrocortisone therapy remains unclear.
  • Emerging evidence suggests patients may respond differently to therapy based on underlying biological profiles, but these differences are not currently used to guide treatment.

Aims

  • The main goal of this project is to determine whether adding fludrocortisone to hydrocortisone improves survival and functional recovery in septic shock.
  • Transcriptomic and immunological profiles’ influence on response to fludrocortisone will also be assessed.

Method

  • This is a Phase 3 multi-centre, adaptive, randomised, blinded, placebo-controlled trial.
  • Participants will be randomised to either:
    • 50 mcg of fludrocortisone daily, or
    • 100 mcg of fludrocortisone daily, or
    • Matching oral or enteral placebo
    for up to 7 days.

Potential Impact

  • The findings have the potential to improve survival and reduce organ dysfunction in septic shock, a condition with persistent mortality and limited effective pharmacological therapies.
  • By evaluating transcriptomic and immunological endotypes, the study may enable a precision medicine approach, allowing treatments to be tailored to patient-specific biological profiles.

Fast Facts

  • Globally, there are an estimated 166M sepsis cases and 21M deaths, accounting for one third of all deaths globally.
  • Septic shock has a mortality of around 30% despite current treatment, highlighting a critical unmet need for effective therapies.
  • Intensive care physicians show considerable variation and uncertainty in the use of fludrocortisone for septic shock, with only a small proportion reporting they consistently use it.

Project Cycle

2025–2030

Partners

  • The George Institute for Global Health, Australia
  • Australian and New Zealand Intensive Care Society Clinical Trial Group (ANZICS CTG)
  • Sepsis Australia and their Consumer Partner and Advocacy Program (SACPAP)

Supporters

National Health and Medical Research Council (NHMRC), Australia

Medical Research Future Fund (MRFF)

Study Chief Principal Investigators

Prof Bala Venkatesh (Australia)
A/Prof Naomi Hammond (Australia)