A Phase 3 interventional study of Fludrocortisone 50 mcg daily and Fludrocortisone 100 mcg daily in Septic Shock, sponsored by The George Institute. Recruiting at 8 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by The George Institute · Phase 3, Interventional, and Treatment
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.
895 studies on the registry are indexed under Shock, Septic; 212 are open to participants now.
This study's planned enrollment of 2,200 is above the median of 78 across 549 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →The George Institute is the lead sponsor of 57 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Being treated with one of the following:
Exclusion Criteria:
The intervention will be fludrocortisone acetate 50 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
Drug: Fludrocortisone 50 mcg daily
The intervention will be fludrocortisone acetate 100 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
Drug: Fludrocortisone 100 mcg daily
Matching placebo tablet dosed daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
Drug: Placebo
The intervention will be fludrocortisone acetate 50 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
The intervention will be fludrocortisone acetate 100 mcg daily, administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
The intervention will be placebo tablet administered orally or via an in situ gastric tube for 7 days or until discharge from ICU, whichever is sooner.
Days alive and free of organ support to day 28
Number of days during the first 28 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy.
Time frame: From randomisation through day 28 after randomisation.
All-cause mortality
Percentage of participants who have died from any cause by each specified follow-up time point. Mortality will be assessed separately at 28 days, 90 days, 6 months and 12 months after randomisation.
Time frame: 28 days, 90 days, 6 months and 12 months after randomisation
Days alive and free of organ support to day 90
Number of days during the first 90 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy.
Time frame: From randomisation through day 90 after randomisation.
Proportion of patients treated with new-onset renal replacement therapy
Percentage of participants who commence renal replacement therapy after randomisation and on or before day 90.
Time frame: From randomisation through day 90 after randomisation.
Days alive and free of invasive mechanical ventilation through day 90
Number of days during the first 90 days after randomisation on which the participant is alive and does not receive invasive mechanical ventilation
Time frame: From randomisation through day 90 after randomisation
Days alive and outside the intensive care unit through day 90
Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to an intensive care unit
Time frame: From randomisation through day 90 after randomisation
Days alive outside hospital through day 90
Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to hospital.
Time frame: From randomisation through day 90 after randomisation
Number of hospital readmissions through day 90
Number of hospital readmissions per participant following discharge from the index hospital admission and occurring on or before day 90 after randomisation.
Time frame: 90 days after randomisation
Number of new-onset infections during the index hospital admission
Number of new-onset infections per participant during the index hospital admission, defined by commencement of new antibiotic treatment at least 2 days after randomisation. Antibiotics commenced for perioperative prophylaxis are excluded. Includes new-onset bacteraemia.
Time frame: From 2 days after randomisation until discharge from the index hospital admission.
Functional status assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Functional status will be assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Each item is scored from 0 (no difficulty) to 4 (extreme difficulty or inability to perform the activity), giving a total score ranging from 0 to 48. Higher scores indicate greater disability and worse functional status.
Time frame: 90 days, 6 months and 12 months after randomisation.
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) index score
EuroQol (Quality of life) 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Health-related quality of life will be assessed using the country-appropriate EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. '5-D' Refers to the five dimensions of health it measures: Mobility, Usual activities, Self-care, Pain/discomfort, Anxiety/depression. '5-L' refers to the five response levels for each dimension, which are: no problems, slight, moderate, severe, extreme/unable to. Responses will be converted into an index score using the applicable country-specific value set. Higher scores indicate better health-related quality of life.
Time frame: 90 days, 6 months and 12 months after randomisation.
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS) index score
Measuring the participant's self-rated overall health on a 0-100 scale, with 100 being the best and 0 the worst.
Time frame: 90 days, 6 months and 12 months after randomisation.
Percentage of participants with hypokalaemia
Percentage of participants with at least one measured blood potassium concentration \<3.5 mmol/L
Time frame: From randomisation through day 8 after randomisation.
Percentage of participants with hyperkalaemia
Percentage of participants with at least one measured blood potassium concentration \>5.0 mmol/L
Time frame: From randomisation through day 8 after randomisation.
Percentage of participants with hyponatraemia
Percentage of participants with at least one measured blood sodium concentration \<135 mmol/L.
Time frame: From randomisation through day 8 after randomisation.
Percentage of participants with hypernatraemia
Percentage of participants with at least one measured blood sodium concentration \>150 mmol/L during the assessment period.
Time frame: From randomisation through day 8 after randomisation.
Average daily net fluid balance in millilitres
Daily net fluid balance is calculated as total recorded fluid input minus total recorded fluid output during each daily recording interval, expressed in millilitres
Time frame: Daily measurements from baseline through day 8 after randomisation.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2030, 41 months later.
Of 40 non-industry phase 3 interventional studies under Shock, Septic, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's planned 41 months is close to that.
Counting every sponsor, half of 41 studies reached it within 42 months; a quarter within 17 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Fludrocortisone
The George Institute