Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weaknesss

NCT04313101 | Unknown

• 1 other identifier: FMASU R 10/2020
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Abnormalities; ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• Association between thyroid dysfunction and ICUAW

  Comparison between both groups as regards thyroid functions and the incidence of each of the four categories of thyroid function.Logistic regression will be done to assess each of the four categories of thyroid function as a risk factor in the development of ICUAW in the presence of other risk factors.

  Patients admitted to the intensive care for more than 7 days

Study Arms (2)

Cases (ICUAW)

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

Other: withdrawl of blood samples for thyroid function testing

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.

Other: withdrawl of blood samples for thyroid function testing

Interventions

withdrawl of blood samples for thyroid function testing 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Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH (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.

Cases (ICUAW); Controls

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

Clinical criteria for Intensive care unit acquired weakness : 1. . Weakness developing after the onset of critical illness 2. . Generalized (Proximal and distal), symmetrical and flaccid weakness with sparing of cranial nerves 3. . MRC) score\< 48 (or mean score \<4 in all tested muscles on more than two occasions more than 24 hours apart) . 4. . Mechanical ventilator dependence 5. . Cause of weakness not related directly to the underlying critical illness * Final Diagnosis of ICUAW : 1. Presence of criteria (1), (2) and (5) + (3) Or (4) 2. Results of Nerve conduction studies Nerve conduction studies :Unilateral bedside nerve conduction tests of the sural and peroneal nerves (reduced CMAP amplitudes).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Abbaseya, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Central Study Contacts

Tarek S Shabana, MD

CONTACT

01001594109; tarek.shabana@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tarek Samir Shabana

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: February 20, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

EG (1)