Septic Shock
Conditions
Keywords
septic shock, hydrocortisone, fludrocortisone, mortality
Brief 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.
Detailed description
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, and septic shock represents its most severe form, characterized by profound circulatory and metabolic abnormalities with high mortality. Current international guidelines recommend intravenous hydrocortisone as adjunctive therapy in patients with septic shock who remain hypotensive despite adequate fluid resuscitation and vasopressor treatment. However, critically ill patients may exhibit relative deficiencies of both glucocorticoid and mineralocorticoid activity, and hydrocortisone alone may not fully meet the physiological demands under severe stress. In recent years, combination therapy with hydrocortisone and fludrocortisone has been investigated, but published trials have reported inconsistent results regarding mortality, shock reversal, and adverse events. Therefore, this randomized controlled trial aims to evaluate the efficacy and safety of hydrocortisone combined with fludrocortisone, compared with standard therapy, in patients with septic shock.
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.
OTHERStandard 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
Northern Jiangsu People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90 days after randomization | All-cause mortality at day 90 after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days after randomization | All-cause mortality at day 28 after randomization |
| ICU mortality | From randomization to ICU discharge (up to 90 days) | All-cause mortality at ICU discharge |
| Hospital mortality | From randomization to hospital discharge (up to 90 days) | All-cause mortality at hospital discharge |
Countries
China
Contacts
CONTACTQingquan Lyu, Master
CONTACTXiaohua Gu, Master
PRINCIPAL_INVESTIGATORQingquan Lyu, Master
Northern Jiangsu People's Hospital
Outcome results
None listed