Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 90

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment336 (estimated)
SponsorNorthern Jiangsu People's Hospital
Academic / other
Locations1 site (Yangzhou, Jiangsu)
StatusRecruiting
StartedMarch 2, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedMarch 4, 2026
Trial IDNCT07383103 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

  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.