Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrocortisone plus Fludrocortisone, Standard care.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial
Overview
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
- 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.
Primary outcome measures
- 90-day mortality [Time frame: 90 days after randomization]
Secondary outcome measures (3)
- 28-day mortality [Time frame: 28 days after randomization]
- ICU mortality [Time frame: From randomization to ICU discharge (up to 90 days)]
- Hospital mortality [Time frame: From randomization to hospital discharge (up to 90 days)]
Eligibility 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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Northern Jiangsu People's Hospital — Yangzhou
Identifiers
NCT: NCT07383103 · 2025ky387