Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock

Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, and septic shock represents its most severe form, characterized by profound circulatory and metabolic abnormalities with high mortality.

Current international guidelines recommend intravenous hydrocortisone as adjunctive therapy in patients with septic shock who remain hypotensive despite adequate fluid resuscitation and vasopressor treatment. However, critically ill patients may exhibit relative deficiencies of both glucocorticoid and mineralocorticoid activity, and hydrocortisone alone may not fully meet the physiological demands under severe stress. In recent years, combination therapy with hydrocortisone and fludrocortisone has been investigated, but published trials have reported inconsistent results regarding mortality, shock reversal, and adverse events.

Therefore, this randomized controlled trial aims to evaluate the efficacy and safety of hydrocortisone combined with fludrocortisone, compared with standard therapy, in patients with septic shock.

Inclusion Criteria:

(1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.

Exclusion Criteria:

Patients meeting any of the following conditions will be excluded:

1. Systemic corticosteroid therapy within the last 3 months before septic shock;
2. High-dose steroid therapy;
3. Immunosuppression;
4. Pregnant;
5. Known allergy to hydrocortisone or fludrocortisone;
6. Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;
7. Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
8. Refusal of the attending staff or patient family;
9. Current participation in another clinical trial.