Euthyroid Sick SyndromeNCT06983418
Euthyroid Sick Syndrome in Obesity Hypoventilation Syndrome
An observational study of Euthyroid Sick Syndrome and Obesity Hypoventilation Syndrome (OHS), run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the frequency and clinical impact of Euthyroid Sick Syndrome (ESS) in patients with Obesity Hypoventilation Syndrome (OHS) who are admitted to the intensive care unit (ICU) for acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Euthyroid Sick Syndrome, Obesity Hypoventilation Syndrome (OHS)
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 30 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included adult patients (aged 18 years and older) with Obesity Hypoventilation Syndrome (OHS) who were admitted to the Intensive Care Unit (ICU) at Mansoura University Hospital in Mansoura, Egypt, for acute hypercapnic respiratory failure. Patients were enrolled between September 2021 and October 2023 and underwent thyroid function testing within 24 hours of ICU admission. The population was drawn from a tertiary care academic center serving a broad urban and rural population in the Nile Delta region.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of Obesity Hypoventilation Syndrome (OHS), either pre-existing or newly established during ICU admission
- Admitted to the intensive care unit (ICU) with acute hypercapnic respiratory failure, defined as:
- Arterial pH < 7.35
- PaCO₂ > 45 mmHg
- Thyroid function tests performed within 24 hours of ICU admission
- Written informed consent provided by patient
Who cannot join
- Known history of thyroid disease (e.g., hypothyroidism, hyperthyroidism, thyroiditis, central hypothyroidism)
- Presence of acute conditions known to affect thyroid function tests, including:
- Sepsis
- Pneumonia
- Active malignancy
- Liver cirrhosis
Show all 12Show fewer
- Kidney failure
- Heart failure
- Use of medications affecting thyroid function, including:
- Corticosteroids
- Amiodarone
- Iodinated contrast agents
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Mansoura University
Al Mansurah, Dakahlia/Egypt, 35511
About this study
Official title: Euthyroid Sick Syndrome in Severe Obesity Hypoventilation Patients Admitted to Intensive Care Unit; Incidence, Risk Factors and Outcome
The goal of this observational study is to learn about the frequency and clinical impact of Euthyroid Sick Syndrome (ESS) in patients with Obesity Hypoventilation Syndrome (OHS) who are admitted to the intensive care unit (ICU) for acute respiratory failure.
The main question it aims to answer is:
Read more
How common is ESS in critically ill OHS patients, and does it affect the severity of illness and ICU outcomes?
Participants with OHS who are admitted to the ICU will have blood tests for thyroid hormone levels (TT3, TT4, and TSH) within 24 hours of admission. Researchers will compare illness severity, oxygen levels, need for breathing support, ICU stay duration, and outcomes between those with and without ESS.
Read the detailed description
Obesity Hypoventilation Syndrome (OHS) is a serious respiratory condition that often requires ICU admission during acute decompensation. Emerging evidence suggests a potential link between systemic hypoxia and alterations in thyroid hormone levels, known as Euthyroid Sick Syndrome (ESS). While ESS is well documented in critical illness, its prevalence and clinical implications in the context of OHS remain poorly defined.
This prospective cross-sectional study was conducted in a tertiary ICU and enrolled adult patients admitted with acute respiratory failure attributed to OHS. The objective was to assess the prevalence of ESS and explore its association with clinical severity and ICU outcomes. Thyroid function tests, including total triiodothyronine (TT3), total thyroxine (TT4), and thyroid-stimulating hormone (TSH), were measured within 24 hours of ICU admission. ESS was defined by a low TT3 level, with or without reductions in TT4 and TSH, in the absence of known thyroid disease.
Additional data collected included arterial blood gas parameters, ventilatory support requirements (including non-invasive ventilation settings), and APACHE II scores. The study compared ICU course and outcomes, such as length of stay, need for invasive ventilation, and in-hospital mortality, between patients with and without ESS.
This study intends to clarify the clinical significance of thyroid dysfunction in OHS and examine whether ESS reflects a state of increased disease burden in these patients.
- Keywords
- Euthyroid Sick Syndrome, Obesity Hypoventilation Syndrome, Acute Respiratory Failure
- Medical subject headings
- Euthyroid Sick Syndromes, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESS Group - OHS Patients with Euthyroid Sick Syndrome | Participants with Obesity Hypoventilation Syndrome (OHS) admitted to the intensive care unit (ICU) for acute hypercapnic respiratory failure who were diagnosed with Euthyroid Sick Syndrome (ESS). ESS was defined by low total triiodothyronine (TT3) levels, with or without low total thyroxine (TT4) and/or thyroid-stimulating hormone (TSH), measured within 24 hours of ICU admission. | |
| Non-ESS Group - OHS Patients without Euthyroid Sick Syndrome | Participants with Obesity Hypoventilation Syndrome (OHS) admitted to the ICU for acute hypercapnic respiratory failure who had normal thyroid function tests (TT3, TT4, and TSH) and did not meet criteria for Euthyroid Sick Syndrome, based on testing within 24 hours of ICU admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Measured: During ICU stay (assessed up to 28 days)
Secondary outcomes (2)
ICU Length of Stay
Measured: Duration of ICU admission (assessed up to 28 days)
Need for Invasive Mechanical Ventilation
Measured: During ICU stay (assessed up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Sep 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euthyroid Sick SyndromeStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983418
- Sponsor's protocol ID
- R.21.08.1406
- Status last verified
- Sep 2021
- First submitted
- 2 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Euthyroid Sick Syndrome in Severe Obesity Hypoventilation Patients Admitted to Intensive Care Unit; Incidence, Risk Factors and Outcome
- ClinicalTrials.gov ID
- NCT06983418
- Acronym / sponsor ID
- R.21.08.1406
- Keywords
- Euthyroid Sick Syndrome, Obesity Hypoventilation Syndrome, Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 21 May 2025 (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.
The goal of this observational study is to learn about the frequency and clinical impact of Euthyroid Sick Syndrome (ESS) in patients with Obesity Hypoventilation Syndrome (OHS) who are admitted to the intensive care unit (ICU) for acute respiratory failure.
The main question it aims to answer is:
How common is ESS in critically ill OHS patients, and does it affect the severity of illness and ICU outcomes?
Participants with OHS who are admitted to the ICU will have blood tests for thyroid hormone levels (TT3, TT4, and TSH) within 24 hours of admission. Researchers will compare illness severity, oxygen levels, need for breathing support, ICU stay duration, and outcomes between those with and without ESS.
Detailed description
Obesity Hypoventilation Syndrome (OHS) is a serious respiratory condition that often requires ICU admission during acute decompensation. Emerging evidence suggests a potential link between systemic hypoxia and alterations in thyroid hormone levels, known as Euthyroid Sick Syndrome (ESS). While ESS is well documented in critical illness, its prevalence and clinical implications in the context of OHS remain poorly defined.
This prospective cross-sectional study was conducted in a tertiary ICU and enrolled adult patients admitted with acute respiratory failure attributed to OHS. The objective was to assess the prevalence of ESS and explore its association with clinical severity and ICU outcomes. Thyroid function tests, including total triiodothyronine (TT3), total thyroxine (TT4), and thyroid-stimulating hormone (TSH), were measured within 24 hours of ICU admission. ESS was defined by a low TT3 level, with or without reductions in TT4 and TSH, in the absence of known thyroid disease.
Additional data collected included arterial blood gas parameters, ventilatory support requirements (including non-invasive ventilation settings), and APACHE II scores. The study compared ICU course and outcomes, such as length of stay, need for invasive ventilation, and in-hospital mortality, between patients with and without ESS.
This study intends to clarify the clinical significance of thyroid dysfunction in OHS and examine whether ESS reflects a state of increased disease burden in these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESS Group - OHS Patients with Euthyroid Sick Syndrome | – | –Participants with Obesity Hypoventilation Syndrome (OHS) admitted to the intensive care unit (ICU) for acute hypercapnic respiratory failure who were diagnosed with Euthyroid Sick Syndrome (ESS). ESS was defined by low total triiodothyronine (TT3) levels, with or without low total thyroxine (TT4) and/or thyroid-stimulating hormone (TSH), measured within 24 hours of ICU admission. |
| Non-ESS Group - OHS Patients without Euthyroid Sick Syndrome | – | –Participants with Obesity Hypoventilation Syndrome (OHS) admitted to the ICU for acute hypercapnic respiratory failure who had normal thyroid function tests (TT3, TT4, and TSH) and did not meet criteria for Euthyroid Sick Syndrome, based on testing within 24 hours of ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included adult patients (aged 18 years and older) with Obesity Hypoventilation Syndrome (OHS) who were admitted to the Intensive Care Unit (ICU) at Mansoura University Hospital in Mansoura, Egypt, for acute hypercapnic respiratory failure. Patients were enrolled between September 2021 and October 2023 and underwent thyroid function testing within 24 hours of ICU admission. The population was drawn from a tertiary care academic center serving a broad urban and rural population in the Nile Delta region.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Diagnosis of Obesity Hypoventilation Syndrome (OHS), either pre-existing or newly established during ICU admission
- Admitted to the intensive care unit (ICU) with acute hypercapnic respiratory failure, defined as:
- Thyroid function tests performed within 24 hours of ICU admission
- Written informed consent provided by patient
Key exclusion criteria (12 listed)
- Known history of thyroid disease (e.g., hypothyroidism, hyperthyroidism, thyroiditis, central hypothyroidism)
- Presence of acute conditions known to affect thyroid function tests, including:
- Use of medications affecting thyroid function, including:
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
ICU Mortality
Time frame: During ICU stay (assessed up to 28 days)
2 secondary outcomes
ICU Length of Stay
Time frame: Duration of ICU admission (assessed up to 28 days)
Need for Invasive Mechanical Ventilation
Time frame: During ICU stay (assessed up to 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Related trials for Euthyroid Sick Syndrome
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Euthyroid Sick Syndrome and Obesity Hypoventilation Syndrome (OHS), run by Mansoura University at 1 site in Egypt.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: During ICU stay (assessed up to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.