Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock
NCT07383103 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 336
Last updated 2026-03-04
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.
Conditions
- Septic Shock
Interventions
- DRUG
-
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.
- OTHER
-
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.
Sponsors & Collaborators
-
Northern Jiangsu People's Hospital
lead OTHER
Principal Investigators
-
Qingquan Lyu, Master · Northern Jiangsu People's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-02
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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