An observational study in Euthyroid Sick Syndrome and Obesity Hypoventilation Syndrome (OHS), sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Mansoura University · Observational
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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.
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.
73 studies on the registry are indexed under Obesity Hypoventilation Syndrome; 10 are open to participants now.
This study's enrollment of 49 is close to the median of 50 across 25 observational studies indexed under Obesity Hypoventilation Syndrome.
Browse Obesity Hypoventilation Syndrome studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Admitted to the intensive care unit (ICU) with acute hypercapnic respiratory failure, defined as:
Exclusion Criteria:
Presence of acute conditions known to affect thyroid function tests, including:
Use of medications affecting thyroid function, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
ICU Mortality
Time frame: During ICU stay (assessed up to 28 days)
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)
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Oct 2023, 25 months.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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