NCT07451886 Adjunctive Fludrocortisone in Septic Shock
| NCT ID | NCT07451886 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2026-04-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07451886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07451886 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07451886 currently recruiting?
Yes, NCT07451886 is actively recruiting participants. Contact the research team at lowell.ling@cuhk.edu.hk for enrollment information.
Where is the NCT07451886 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong, Hong Kong and 1 additional location.
Who is sponsoring the NCT07451886 clinical trial?
NCT07451886 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 32 participants.