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

NCT ID: NCT06537180

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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The Female Group

Patients are categorized as females according to their apparent gender.

No interventions assigned to this group

The Male Group

Patients are categorized as males according to their apparent gender.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine, Alexandria University Hospitals

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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GBD-HYDRO

Identifier Type: -

Identifier Source: org_study_id

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