Thyroid and Adrenal Disorders in ICU

November 17, 2025 updated by: Radwa mahmoud elsayed, Assiut University

Thyroid and Adrenal Disorders in ICU Patients With Septic Shock

A dysregulated host response to infection results in organ failure and sepsis, a potentially fatal illness. Sepsis killed about 11 million people worldwide in 2017 and had a death rate close to 20 %

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sepsis syndromes span a clinical continuum with variable prognoses. Septic shock, the most severe complication of sepsis, carries high mortality. In response to an inciting agent, pro-inflammatory and anti-inflammatory arms of the immune system are activated in concert with the activation of monocytes, macrophages, and neutrophils that interact with the endothelium through pathogen recognition receptors to elaborate cytokines, proteases, kinins, reactive oxygen species, and nitric oxide .Sepsis syndromes caused by multidrug-resistant bacterial strains (methicillin-resistant Staphylococcus, vancomycin-resistant enterococci are on the rise with a current incidence of up to 25%; viruses and parasites cause far fewer cases and are identified in 2% to 4% of cases . It is a well-known fact that the thyroid gland plays an important role in regulating metabolism, growth, and development by secretion of hormones such as thyroxine (T4) and triiodothyronine (T3). In critical illness, changes occur in the hypothalamic-pituitary-thyroid (HPT) axis which leads to euthyroid sick syndrome or non-thyroidal illness syndrome (NTIS). This condition is characterized by decreased T3 levels, normal to low levels of T4, and normal to decreased thyroid-stimulating hormone (TSH) levels despite the absence of intrinsic thyroid disease in patients. The pathophysiology of NTIS involves alterations in thyroid hormone production, peripheral conversion of T4 to T3, and increased degradation of thyroid hormones. During critical illness, cytokines and inflammatory mediators such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) play a significant role in these hormonal changes. Reduced activity of deiodinases, enzymes responsible for the conversion of T4 to T3, further contributes to decreased T3 levels. Critical illness is associated with increased systemic cortisol availability, a vital part of the stress response. Stress can cause life-threatening adrenal crisis when a disease of the hypothalamic-pituitary-adrenal (HPA) axis is present and not adequately treated with stress doses of hydrocortisone. Hence understanding these changes is vital to improve prognosis in patients under intensive care. For instance, in the absence of adrenal insufficiency, stress doses of hydrocortisone can be used to reduce the high vasopressor need in patients suffering from septic shock .In response to stress, adrenal gland generates high levels of glucocorticoid (GC). We call this induced GC (IGC). Unfortunately, 25-60% of septic patients experience relative adrenal insufficiency (RAI). RAI is defined by impaired IGC production in response to stress, which is diagnosed by a delta total cortisol of < 9 μg/dL post-ACTH stimulation. Thus, understanding the endocrine changes and correction of these hormone levels as early as possible may reduce the hospitalization duration, thereby improving the prognosis of the patients. However, there is a lacuna in the literature regarding the level of these hormones at various timelines in critically ill patients classified according to the APACHE II classification in India. With the available data, we aimed to determine the thyroid and cortisol changes in acute severely ill patients and to assess their relationship with the severity of illness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt
        • Radwa mahmoud
        • Contact:
          • Assuit U Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with septic shock admitted at intensive care unit and their age is above 18 years old

Description

Inclusion criteria

  • All Patients who match the diagnostic criteria for sepsis/septic shock as stated
  • admitted in ICU

Exclusion Criteria:

  1. Patients refuse to be enrolled in the study
  2. Patients with previous endocrinal disorders.
  3. Patients receiving corticosteroid or thyroid hormonal therapy.
  4. Pregnancy or lactation.
  5. Previous endocrinal gland surgery.
  6. Individuals with pacing rhythms, bundle branch blocks (QRS interval >120 ms),

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with septic shock in the ICU
Blood sampling for thyroid and adrenal hormones
Diagnostic test: Blood sampling
Blood sampling for the hormones

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum Thyroid and adrenal hormones levels
Time Frame: 24 hours
measurement of thyroid and adrenal hormones (TSH-FT3-FT4 - cortisol level ) will be measured by ELLISA technique in septic shock patients at ICU.
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Radwa m elsayed, MB, Assuit University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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