RecruitingPhase 2NCT07451886

Adjunctive Fludrocortisone in Septic Shock

Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)

Sponsor

Chinese University of Hong Kong

Enrollment

32 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Sepsis Septic Shock Sepsis and septic shock Sepsis - to Reduce Mortality in the Intensive Care Unit Sepsis at Intensive Care Unit

Summary

Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone. To test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
≥0.25 μg/kg/min of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour
onset of septic shock within 24 hours
shock due to infection with no other proven or apparent cause
hypoperfusion defined as arterial or venous lactate concentration >2.0 mmol/L
mechanical ventilation

Exclusion Criteria9

fludrocortisone cannot be administered within 24 hours of onset of septic shock
death is deemed imminent or inevitable by treating clinicians
limitation of therapy
an underlying disease process with a life expectancy of less than 90 days
pregnancy (confirmed or suspected)
receiving immunomodulatory agents including hydrocortisone > 300mg/day
enteral medication cannot be administered
prescribed fludrocortisone for other medical condition
contraindication to hydrocortisone or fludrocortisone

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Interventions

DRUGFludrocortisone 100 mcg daily

Patients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.

DRUGPlacebo

Patients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.