Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a large, international, randomized, double-blind phase 3 study enrolling up to about 2,200 critically ill adults with septic shock. Participants receive hydrocortisone and are randomized to receive fludrocortisone at two dose levels or placebo to see which regimen best supports survival and organ recovery. The study also explores whether individual immune or gene expression profiles influence treatment response. Outcomes include mortality, organ support-free days, and quality of life up to one year after treatment. Conducted at several ICUs across Australia and other countries, the trial seeks a personalized approach to steroid use in septic shock.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Shock presumed due to infection
2. Treatment with vasopressors to maintain a Systolic Blood Pressure (SBP) \>90mmHg or Mean Arterial Pressure (MAP) \> 65mmHg, after having received adequate fluid resuscitation (in the opinion of the treating clinician)
3. Plasma lactate concentration \>2mmol/L
4. Being treated with hydrocortisone 200mg/day as adjunctive treatment for septic shock
5. Being treated with one of the following:

   1. Invasive Mechanical Ventilation OR
   2. Non-invasive ventilation (CPAP or BiPAP) OR
   3. Oxygen supplementation with an oxygen flow of \>10L/min independent of delivery system and an FiO2 of 0.5 or above., OR
   4. Use of Veno-venous ECMO

Exclusion Criteria:

1. Met all inclusion criteria for more than 12 hours
2. Death is deemed imminent or inevitable by treating ICU specialist
3. Patients with documented systemic fungal infection at the time of randomisation
4. Patients with documented allergy to fludrocortisone
5. Patients unable to receive enteral medications
6. An underlying disease process with a life expectancy of less than 28 days
7. Pregnancy (confirmed or suspected)
8. Receiving hydrocortisone (HC) or fludrocortisone (FC) for conditions other than septic shock
9. Prior enrolment in this trial
10. Known or documented objections to research participation

Where it's running

• Princess Alexandra Hospital
  Brisbane, Queensland, Australia Recruiting
• Austin Hospital
  Melbourne, Victoria, Australia Recruiting
• Nepean Hospital
  Penrith, New South Wales, Australia Not yet recruiting
• Royal North Shore Hospital
  Sydney, New South Wales, Australia Not yet recruiting
• Royal Brisbane and Women's hospital
  Brisbane, Queensland, Australia Not yet recruiting
• Caboolture Hospital
  Caboolture, Queensland, Australia Not yet recruiting

Study contacts

• Principal investigator: Professor Balasubramanian (Bala) Venkatesh — The George Institute
• Study coordinator: Senior Project Manager
• Email: fludroshock@georgeinstitute.org.au
• Phone: +61 2 8052 4460

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.