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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response

RecruitingPhase 3Ages 18 Years - anyAllThe George Institute
NCT07898462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Fludrocortisone 50 mcg daily
  • Fludrocortisone 100 mcg daily
  • Placebo
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Where

8 sites
Nepean Hospital
Penrith, Australia
Royal North Shore Hospital
Sydney, Australia
Royal Brisbane and Women's hospital
Brisbane, Australia
Princess Alexandra Hospital
Brisbane, Australia
Caboolture Hospital
Caboolture, Australia
Gold Coast University Hospital
Gold Coast, Australia
The Queen Elizabeth Hospital
Adelaide, Australia
Austin Hospital
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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