Adjunctive Fludrocortisone in Septic Shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot multicenter, randomized, double-blind, placebo-controlled trial will enroll 32 adults with septic shock requiring mechanical ventilation in ICUs across Hong Kong, Australia, and Singapore. Participants will receive either enteral fludrocortisone 100 mcg daily or placebo for up to 7 days, with outcomes focused on feasibility criteria and secondary clinical measures. Feasibility endpoints include protocol adherence, concealment, retention, and data completeness, while secondary outcomes examine time to shock resolution, 28-day mortality, organ-support-free days, and electrolyte safety. The study aims to determine whether a larger international trial comparing hydrocortisone alone versus combination therapy is practicable and informative for practice change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection
2. ≥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
3. onset of septic shock within 24 hours
4. shock due to infection with no other proven or apparent cause
5. hypoperfusion defined as arterial or venous lactate concentration \>2.0 mmol/L
6. mechanical ventilation

Exclusion Criteria:

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

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting
• North District Hospital
  Hong Kong, Hong Kong Not yet recruiting
• Pamela Youde Nethersole Hospital
  Hong Kong, Hong Kong Not yet recruiting
• Princess Margaret Hospital
  Hong Kong, Hong Kong Not yet recruiting
• Queen Mary Hospital
  Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Study coordinator: Lowell Ling, MBBS
• Email: lowell.ling@cuhk.edu.hk
• Phone: (852) 35052735

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.