Thyroid and Cortisol Hormone Response to Sepsis

February 28, 2024 updated by: Sara Mahmoud khalf allah Mohamed, Assiut University

Thyroid and Cortisol Hormone Response in Patients With Sepsis Who Attended To Assiut University Hospitals (ICU)

Thyroid and cortisol hormone response to sepsis

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Sepsis is dysregulated host response to infection that results in life-threatening organ dysfunction. Virtually every body system can be affected by this syndrome to greater or lesser extents.

Endocrine alterations are well characterised in sepsis with variations in circulating blood levels and/or receptor resistance.

In response to any psychological or physical stressor, there is widespread neurohormonal activation to adapt body with the stressor. Production and secretion of stress hormones increase to modulate behaviour Many studies have been performed investigating specific hormonal perturbations such as critical illness-induced corticosteroid insufficiency ,all of which are associated with worse outcomes and poor of body inflammation. However, the endocrine system as a whole has been largely overlooked as a fundamental contributor to the integrated host response to sepsis thyroid axis is affected during sepsis with decreased pituitary release of thyroid stimulating hormone (TSH) and inhibition of the peripheral conversion of thyroxine (T4) by 5-deiodinase to the much more metabolically active triiodothyronine (T3). High cortisol levels also inhibit this enzymatic conversion.

Study Type

Observational

Enrollment (Estimated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of cortisol level and thyroid function response to sepsis in ICU
Time Frame: From time of admission to ICU up to 3rd day after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 20, 2026

Study Completion (Estimated)

October 25, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Thyroid and cortisol in sepsis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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