Euthyroid Sick Syndrome in Obesity Hypoventilation Syndrome

NCT06983418 | Completed

• 1 other identifier: R.21.08.1406
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Euthyroid Sick Syndrome; Obesity Hypoventilation Syndrome (OHS)

Keywords

Euthyroid Sick Syndrome; Obesity Hypoventilation Syndrome; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  During ICU stay (assessed up to 28 days)

Secondary Outcomes (2)

• ICU Length of Stay

  Duration of ICU admission (assessed up to 28 days)

• Need for Invasive Mechanical Ventilation

  During ICU stay (assessed up to 28 days)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Kidney failure
• Heart failure
• Use of medications affecting thyroid function, including:
• Corticosteroids
• Amiodarone
• Iodinated contrast agents

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine Mansoura University

Al Mansurah, Dakahlia/Egypt, 35511, Egypt

Location

MeSH Terms

Conditions

Euthyroid Sick Syndromes; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 21, 2025
• Study Start: September 1, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 21, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)