Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock

NCT07383103 · tracked via the Priya Life Science China tracker

Sponsor

Northern Jiangsu People's Hospital

Phase

Phase 4

Started

2026-03-02

Last updated

2026-03-04

Condition(s) studied

Septic Shock

Investigational drug(s) / intervention(s)

Hydrocortisone plus FludrocortisoneStandard care

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

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.

Primary outcome measure(s)

90-day mortality — 90 days after randomization
All-cause mortality at day 90 after randomization

Trial sites (1)

Facility	City	Region	Status
Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07383103 on ClinicalTrials.gov ↗ ← All trials in China