Adjunctive Fludrocortisone in Septic Shock

Sponsored by Chinese University of Hong Kong

About this trial

Last updated 3 months ago

Study ID

2024.398

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18+ Years

All Sexes

Trial Timing

Started 2 months ago

What is this trial about?

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.

What are the participation requirements?

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