Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weaknesss

NCT ID: NCT04313101

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2020-05-31

Brief Summary

Intensive care unit-acquired weakness (ICU-AW) is the most common neuromuscular impairment in critically ill patients. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.Thyroid disorders are also associated with neuromuscular abnormalities and may decrease the threshold for the development of any type of myopathy. However, no previous study investigated the direct relationship between thyroid dysfunction and ICUAW.This study aims at evaluation of the association between thyroid dysfunction and intensive care unit acquired weakness.

Detailed Description

Intensive care unit acquired weakness refers to muscle weakness encountered in the intensive care unit as a consequence of critical illness. It affects more than 50 % of patients in the intensive care and is related to many problems as difficult weaning from mechanical ventilation, prolonged hospital stay and increased mortality.

There are three distinct entities for ICUAW that can only be differentiated by neurophysiological studies. These are critical illness myopathy (CIM), critical illness polyneuropathy (CIP) and critical illness neuromyopathy (CINM).

Identification of risk factors responsible for the development of ICUAW is the first step in the prevention and management of this disorder. Till time septic shock, hyperglycemia, high dose steroid therapy, prolonged mechanical ventilation and the use of neuromuscular blocking agents are the main accused.

Thyroid disorders are also associated with neuromuscular abnormalities. Unfortunately, the prevalence of thyroid dysfunction in the intensive care is high reaching 90%. Moreover, patients with severe critical illness, who are typically prone to the development of ICUAW, show changes in their thyroid biochemistry namely low T3 levels (with or without low T4 levels) in the presence of normal TSH levels. These changes are collectively known as Non-Thyroidal illness syndrome (previously low T3 syndrome and Euthyroid sick syndrome) which is the most common form of thyroid dysfunction in the intensive care unit.

Conditions

Thyroid Abnormalities; ICU Acquired Weakness

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases (ICUAW)

57 critically ill patients developing ICUAW during their stay in the intensive care unit will be included in the study as cases.

withdrawl of blood samples for thyroid function testing

Intervention Type: OTHER

Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories

• Euthyroid ( Normal TSH, FT3 and FT4)
• Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3).
• Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4)
• Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels.

Controls

A total of 57 Critically ill patients in the same period who did not develop ICU acquired weakness during their ICU stay will be included as controls.

withdrawl of blood samples for thyroid function testing

Intervention Type: OTHER

Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories

• Euthyroid ( Normal TSH, FT3 and FT4)
• Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3).
• Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4)
• Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels.

Interventions

withdrawl of blood samples for thyroid function testing

Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories

• Euthyroid ( Normal TSH, FT3 and FT4)
• Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3).
• Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4)
• Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes admitted to the general ICU of Ain Shams University Hospitals with critical illness for more than 7 days * Diagnosis of ICU acquired weakness will be made based on clinical criteria for ICUAW and confirmed by nerve conduction studies.

Exclusion Criteria

• Patients with cerebrovascular accidents, neuromuscular disorders, spine abnormalities, spinal cord or head injuries, CNS tumors, secondary thyroid disorders and electrolyte disturbances were excluded from the study. Patients receiving thyroid replacement or anti-thyroid drugs for the treatment of any throid disorder will be also excluded from the study as these drugs may alter their thyroid biochemistry

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Samir Shabana

Tarek Samir Shabana

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University hospitals

Cairo, Abbaseya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tarek S Shabana, MD

Role: CONTACT

tarek.shabana@hotmail.com

01001594109 ext. +20

Other Identifiers

FMASU R 10/2020

Identifier Type: -

Identifier Source: org_study_id