Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock
ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNorthern Jiangsu People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Systemic corticosteroid therapy within the last 3 months before septic shock;
High-dose steroid therapy;
Immunosuppression;
Pregnant;
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrocortisone plus Fludrocortisone
DrugHydrocortisone 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.
Standard care
Other interventionPatients 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.
Treatment groups
336 Participants
are divided into 2 treatment groupsGroup A: Hydrocortisone plus FludrocortisoneExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
90-day mortality
All-cause mortality at day 90 after randomization
Time frame
90 days after randomizationSecondary outcomes
1
28-day mortality
All-cause mortality at day 28 after randomization
Time frame
28 days after randomization2
ICU mortality
All-cause mortality at ICU discharge
Time frame
From randomization to ICU discharge (up to 90 days)3
Hospital mortality
All-cause mortality at hospital discharge
Time frame
From randomization to hospital discharge (up to 90 days)Other outcomes
1
Shock reversal time
Reversal of shock is defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h. Time to shock reversal is defined as the time from randomization to shock reversal.
Time frame
From randomization up to 28 days2
ICU length of stay
Time in days until ICU discharge
Time frame
From randomization to ICU discharge (up to 90 days)3
Hospital length of stay
Time in days until hospital discharge
Time frame
From randomization to hospital discharge (up to 90 days)4
Change in Sequential Organ Failure Assessment (SOFA) score at 72 hours
The Sequential Organ Failure Assessment (SOFA) score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction and worse clinical outcomes. The change in SOFA score (ΔSOFA) is calculated as the SOFA score at enrollment minus the SOFA score at 72 hours after randomization. If a patient is discharged from the ICU within 72 hours, the SOFA score at ICU discharge will be used for analysis.
Time frame
72 hours after randomizationSponsors and contacts
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Source ClinicalTrials.gov