Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock

Northern Jiangsu People's Hospital

Status and phase: Begins enrollment this month; Phase 4

Conditions: Septic Shock

Treatments: Drug: Hydrocortisone plus Fludrocortisone; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT07383103

2025ky387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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336 participants in 2 patient groups

Hydrocortisone plus Fludrocortisone

Experimental group

Description:

Hydrocortisone: 200 mg per day administered by continuous intravenous infusion for up to 7 days or until ICU discharge, whichever occurs first. Fludrocortisone: 50 μg administered orally or via nasogastric tube once daily for up to 7 days or until ICU discharge, whichever occurs first.

Treatment:

Drug: Hydrocortisone plus Fludrocortisone

Standard care

Active Comparator group

Description:

Patients will receive standard care for septic shock according to current international guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures, including the use of hydrocortisone at the discretion of the treating physician, but without fludrocortisone.

Treatment:

Other: Standard care