NCT06537180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 31, 2024

Last Update Submit

August 2, 2024

Conditions

Septic Shock

Keywords

Critical Care, Septic Shock, Hydrocortisone, Gender

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    The rate of all-cause mortality after enrollment

    Day 28

Study Arms (2)

The Female Group

Patients are categorized as females according to their apparent gender.

The Male Group

Patients are categorized as males according to their apparent gender.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAccording to apparent self-identified gender.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with incomplete data sets.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University Hospitals

Alexandria, Egypt

Location

Related Publications (1)

  • Moustafa HAM, Montasser M, Ahmed I, Mansy AEA, Habib T. Impact of sex on outcomes in septic shock patients treated with hydrocortisone. Sci Rep. 2025 Nov 29;15(1):42924. doi: 10.1038/s41598-025-28014-5.

    PMID: 41318782DERIVED

MeSH Terms

Conditions

Shock, SepticCoitus

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

January 1, 2023

Primary Completion

July 30, 2023

Study Completion

August 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)