Hydrocortisone plus fludrocortisone for adults with septic shock

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

This test will see if adding fludrocortisone to hydrocortisone helps adults with septic shock survive and recover circulation faster.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07383103 on ClinicalTrials.gov

What this trial studies

This randomized Phase 4 trial enrolls adults aged 18–90 with septic shock diagnosed within 12 hours and assigns them to receive hydrocortisone plus fludrocortisone or standard care. Treatments are given according to a fixed protocol and patients are followed for outcomes including mortality, shock reversal, and adverse events. Key exclusions include recent systemic corticosteroid use, immunosuppression, pregnancy, active gastrointestinal conditions requiring fasting, anticipated death within 90 days, or concurrent trial participation. The trial is conducted at Northern Jiangsu People's Hospital in Yangzhou, Jiangsu, China.

Who should consider this trial

Good fit: Adults aged 18–90 with a new diagnosis of septic shock within 12 hours who have not recently received systemic corticosteroids and are not immunosuppressed are ideal candidates.

Not a fit: Patients who recently had high-dose steroids, are immunosuppressed, pregnant, have active GI conditions requiring fasting, have a life expectancy under 90 days, or are already in another trial are excluded and unlikely to benefit from enrolling.

Why it matters

Potential benefit: If successful, the combination could reduce deaths and help septic shock patients regain stable circulation more quickly.

How similar studies have performed: Previous trials testing hydrocortisone plus fludrocortisone have been conducted but have reported inconsistent results on mortality and shock reversal.

Eligibility criteria

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.

Where this trial is running

Yangzhou, Jiangsu

• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Qingquan Lyu, Master — Northern Jiangsu People's Hospital
• Study coordinator: Qingquan Lyu, Master

Conditions Septic Shock; septic shock; hydrocortisone; fludrocortisone; mortality