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Clinical Trials/NCT06537180
NCT06537180
Completed
Not Applicable

Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone

Alexandria University1 site in 1 country621 target enrollmentJanuary 1, 2023
ConditionsSeptic Shock

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Alexandria University
Enrollment
621
Locations
1
Primary Endpoint
28-day mortality
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Detailed Description

Because of their pleiotropic effects, corticosteroids are widely used as adjunctive therapy in sepsis for their anti-inflammatory, metabolic, and immune-suppressing actions. Moreover, the treatment benefits of corticosteroids in terms of hemodynamics and organ functions for septic shock were established. Hydrocortisone reduces the duration of mechanical ventilation and critical care treatment and reduces the time needed for shock reversal. Hydrocortisone use at a daily dose of ≤400 mg for at least 3 days was associated with survival benefits. Interestingly, corticosteroid treatment was reported to be more cost-effective in females than in males with septic shock, compared with placebo. This may be explained by the fact that sex hormones modulate the expression and sensitivity of glucocorticoid receptors differently, potentially influencing the body's response to cortisol. To the best of our knowledge, the data available on whether females and males may be more or less likely to acquire a better or worse prognosis of persistent septic shock when treated with hydrocortisone is sparse. The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
August 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients of both sexes with persistent septic shock received hydrocortisone during their intensive care unit (ICU) stay.

Exclusion Criteria

  • Patients with incomplete data sets.

Outcomes

Primary Outcomes

28-day mortality

Time Frame: Day 28

The rate of all-cause mortality after enrollment

Study Sites (1)

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