Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock
Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial
Northern Jiangsu People's Hospital
336 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- (1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.
Exclusion Criteria10
- Patients meeting any of the following conditions will be excluded:
- Systemic corticosteroid therapy within the last 3 months before septic shock;
- High-dose steroid therapy;
- Immunosuppression;
- Pregnant;
- Known allergy to hydrocortisone or fludrocortisone;
- Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;
- Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
- Refusal of the attending staff or patient family;
- Current participation in another clinical trial.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07383103