NCT06289179

Brief Summary

Thyroid and cortisol hormone response to sepsis

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Mar 2024

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2024Oct 2026

First Submitted

Initial submission to the registry

February 16, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2026

Expected
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 16, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pattern of cortisol level and thyroid function response to sepsis in ICU

    Affect of sepsis on hormones at ICU:compare the change of endocrinal hormones ( TSH (mIU/L) .T3(ng/dL) .T4 ( mcg/dL) adrenocorticotropic hormone "ACTH" (pg/mL) , cortisol (µg/dL)) at time of admission, course ICU ,3rd day after discharge

    From time of admission to ICU up to 3rd day after discharge

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

include Adults (≥18 years), both genders, admitted to critical care unit with sepsis Exclusion patient with Previous diagnosis of endocrinal changes (thyroid dysfunction , hypopituitarism, Addison disease, Cushing syndrome)

You may qualify if:

  • The study will include Adults (≥18 years), both genders
  • septic patients admitted to critical care unit

You may not qualify if:

  • thyroid disease
  • hypopituitarism
  • Addison disease
  • Cushing syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Silva MH, Araujo MC, Diniz EM, Ceccon ME, Carvalho WB. Thyroid abnormalities in term infants with fungal sepsis. Rev Assoc Med Bras (1992). 2016 Sep;62(6):561-567. doi: 10.1590/1806-9282.62.06.561.

    PMID: 27849234BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Mahmoud khalf allah Mohamed

CONTACT

Mohamed Hossam Aldin Hassan, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 1, 2024

Study Start

March 1, 2024

Primary Completion

February 20, 2026

Study Completion (Estimated)

October 25, 2026

Last Updated

March 1, 2024

Record last verified: 2024-02