NCT07383103

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Hydrocortisone plus Fludrocortisone	Hydrocortisone will be administered at a dose of 200 mg per day by continuous intravenous infusion. Fludrocortisone will be administered at a dose of 50 μg once daily orally or via nasogastric tube. Both drugs will be given for up to 7 days or until ICU discharge, whichever occurs first.
OTHER	Standard care	Patients will receive standard care for septic shock according to current international and institutional guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures. Fludrocortisone will not be administered.Hydrocortisone may be administered at the discretion of the treating physician.

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-02-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: China