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Completed

NCT Number: NCT06537180

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 28-day mortality

    Time frame: Day 28

    The rate of all-cause mortality after enrollment

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 5, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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