None listed
Conditions
Brief summary
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.
Interventions
Participants receiving intravenous hydrocortisone at a daily dose of 200 mg/day as adjunctive treatment for septic shock and eligible for FLUDRO-SHOCK study, will be randomised to receive either:
1. 50 mcg of oral or enteral fludrocortisone daily, or
2. 100 mcg of oral or enteral fludrocortisone daily, or
3. Matching oral or enteral placebo daily
For seven days or until discharge from intensive care unit (ICU).
The study drug will be administered to patients in the ICU by delegated site team st
Participants receiving intravenous hydrocortisone at a daily dose of 200 mg/day as adjunctive treatment for septic shock and eligible for FLUDRO-SHOCK study, will be randomised to receive either: 1. 50 mcg of oral or enteral fludrocortisone daily, or 2. 100 mcg of oral or enteral fludrocortisone daily, or 3. Matching oral or enteral placebo daily For seven days or until discharge from intensive care unit (ICU). The study drug will be administered to patients in the ICU by delegated site team staff members. To assess adherence to the intervention, monitors will verify that the study drug administration documented in source records (electronic medical records – eMRs) is consistent with the data recorded in the study database.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Critically ill adult patients aged 18 years or older meeting Sepsis-3 criteria for septic shock and receiving high-level respiratory and cardiovascular support will be eligible if they meet all of the following inclusion criteria and no exclusion criteria: 1. Shock presumed due to infection 2. Treatment with a vasopressor infusion to maintain a systolic blood pressure greater than 90 mmHg or a mean arterial pressure greater than or equal to 65 mmHg, after receiving adequate fluid resuscitation (in the opinion of the treating clinician) 3. Plasma lactate concentration greater than 2.0 mmol/L 4. Being treated with intravenous hydrocortisone at a daily dose of 200 mg per day as adjunctive treatment for septic shock 5. Use of one of the following: a) Invasive mechanical ventilation, or b) Non-invasive ventilation (CPAP or BiPAP), or c) Oxygen supplementation with an oxygen flow greater than 10 L/min independent of the delivery system and a fraction of inspired oxygen of 0.5 or above, or d) Veno-venous extracorporeal membrane oxygenation
Exclusion criteria
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 or fludrocortisone for conditions other than septic shock 9. Prior enrolment in this trial 10. Known or documented objections to research participation
Outcome results
None listed