Actively Recruiting
Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)
Led by Chinese University of Hong Kong · Updated on 2026-06-02
32
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Sepsis is a serious condition caused by the body's uncontrolled response to infection, which can lead to septic shock, a life-threatening state. This research evaluates whether adding fludrocortisone to the standard treatment with hydrocortisone might improve outcomes for critically ill patients in shock. The study is a Phase II pilot trial designed to test the feasibility of a larger international study that would confirm if this combination therapy can reduce mortality in septic shock. The trial is a randomized, double-blind, placebo-controlled study conducted in six intensive care units across Hong Kong, Australia, and Singapore. Participants will receive either 100 mcg of enteral fludrocortisone daily or a placebo for up to seven days, alongside standard intravenous hydrocortisone given every six hours. The treatment period lasts until discharge from the ICU or death, whichever occurs first. Participants will be critically ill adults who have septic shock and require mechanical ventilation. Researchers will monitor protocol adherence, recruitment rates, time to shock resolution, mortality at 28 days, days free of organ support, and severe electrolyte imbalances. The study includes detailed tracking of feasibility outcomes, data completeness, and safety over approximately 20 months, with the aim of informing a larger future trial.
CONDITIONS
Brief Title
Adjunctive Fludrocortisone in Septic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with suspected or confirmed sepsis showing an increase of 2 or more points in SOFA score due to infection
- Receiving noradrenaline infusion or vasoactive-inotropic score of 25 or higher to maintain mean arterial pressure of 65 mmHg or more for at least 1 hour
- Onset of septic shock within the last 24 hours
- Shock caused by infection with no other known cause
- Hypoperfusion with arterial or venous lactate concentration above 2.0 mmol/L
- Receiving mechanical ventilation
You will not qualify if you...
- Unable to receive fludrocortisone within 24 hours of septic shock onset
- Death considered imminent or inevitable by doctors
- Limitations on therapy in place
- Life expectancy less than 90 days due to an underlying disease
- Pregnant or suspected pregnancy
- Receiving immunomodulatory agents including hydrocortisone over 300 mg/day
- Unable to take enteral medication
- Already prescribed fludrocortisone for another condition
- Contraindications to hydrocortisone or fludrocortisone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days or until discharge from ICU or death
Participants receive enteral fludrocortisone or placebo daily for up to 7 days or until discharge from ICU or death, whichever comes first. All participants also receive intravenous hydrocortisone every 6 hours for up to 7 days or until discharge from ICU or death.
Daily visits or assessments during ICU stay for up to 7 days
Duration - Up to 28 days after enrollment
Participants are monitored for outcomes including 28-day mortality, organ support-free days, and infection occurrence after treatment ends.
Follow-up assessments up to 28 days after enrollment
Trial Site Locations
Total: 5 locations
1
North District Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
2
Pamela Youde Nethersole Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
3
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
4
Princess Margaret Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
5
Queen Mary Hospital
Hong Kong, Hong Kong
Not Yet Recruiting
Research Team
L
Lowell Ling, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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