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临床试验/NCT04313101
NCT04313101Unknown不适用

Association Between Thyroid Dysfunction and Intensive Care Unit Acquired Weakness: A Case Control Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
114
试验地点
1
主要终点
Association between thyroid dysfunction and ICUAW

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Association between thyroid dysfunction and ICUAW

时间窗: Patients admitted to the intensive care for more than 7 days

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarek Samir Shabana

Tarek Samir Shabana

Ain Shams University

研究点 (1)

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