SepsisNCT06289179
Thyroid and Cortisol Hormone Response to Sepsis
An observational study of Sepsis, run by Assiut University.
Trial summary
Thyroid and cortisol hormone response to sepsis Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 25 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- The study will include Adults (≥18 years), both genders
- septic patients admitted to critical care unit
Who cannot join
- thyroid disease
- hypopituitarism
- Addison disease
- Cushing syndrome)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Thyroid and Cortisol Hormone Response in Patients With Sepsis Who Attended To Assiut University Hospitals (ICU)
Thyroid and cortisol hormone response to sepsis
Read the 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.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From time of admission to ICU up to 3rd day after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mahmoud khalf allah Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289179
- Sponsor's protocol ID
- Thyroid and cortisol in sepsis
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27849234
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid and Cortisol Hormone Response in Patients With Sepsis Who Attended To Assiut University Hospitals (ICU)
- ClinicalTrials.gov ID
- NCT06289179
- Acronym / sponsor ID
- Thyroid and cortisol in sepsis
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroid and cortisol hormone response to sepsis
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- The study will include Adults (≥18 years), both genders
- septic patients admitted to critical care unit
Key exclusion criteria (4 listed)
- thyroid disease
- hypopituitarism
- Addison disease
- Cushing syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 27849234Silva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Mahmoud khalf allah Mohamed (01099929480, saramm302@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.