Hydrocortisone plus fludrocortisone for adults with septic shock
Official title: Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock:A Prospective Randomized Controlled Clinical Trial
Run by Northern Jiangsu People's Hospital · NCT07383103 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 336 (estimated) |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07383103 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous trials testing hydrocortisone plus fludrocortisone have been conducted but have reported inconsistent results on mortality and shock reversal.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: bonhomie2014@163.com
- Phone: 0086-18051063899
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.