Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 590
- 试验地点
- 6
- 主要终点
- Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis.
研究概览
简要总结
AQUA FONTIS is a unicentric, multidisciplinary, prospective cross-section and longitudinal study that aims at the development of a more clear-cut diagnostic definition and classification of non-thyroidal illness syndrome (NTIS).
详细描述
Detailed Description:
Non-thyroidal illness syndrome (NTIS), also referred to as euthyroid sick syndrome (ESS) or thyroid allostasis in critical illness, tumors, uremia and starvation (TACITUS), is a complex endocrine condition that may occur in critically ill patients. It is associated with significantly increased morbidity and mortality.
NTIS is characterised by three components that may occur single or in combination:
- central hypothyroidism (transient thyrotropic insufficiency)
- impaired protein binding of thyroid hormones and
- reduced formation of T3 and increased conversion to rT3 (low-T3-syndrome).
Despite of long lasting research to some of its details NTIS is still poorly characterized in an integrative view. Additionally, it lacks a clinically usable classification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe illness requiring intensive care
- •Stay of at least 24 hours at the ICU
排除标准
- •Substituted hypothyroidism or substitution in case of thyroid carcinoma
- •Hyperthyroidism that is treated with thyrostatic agents and exhibits a THS level not below the reference region
- •Manifest AIDS disease
结局指标
主要结局
Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis.
时间窗: Three weeks after admission to ICU (evaluation point 1.5) and additionally on day of discharge from the hospital (evaluation point 1.999)
Diagnostic accuracy (sensitivity, specificity and AUCs of ROC analysis) of the thyroid's calculated secretory capacity (GT) for differentiation between NTIS and subclinical hyperthyroidism.
次要结局
- Correlation of variables that quantify distinct components of NTIS with independent predictors of evolution, survival or pathophysiological condition and influencing or disturbing factors like medication.(24 hours (evaluation point 1.1), 72 hours (evaluation point 1.2) and further on weekly (evaluation points 1.3 to 1.5) after admission to the intensive care unit up to the day of discharge from hospital (evaluation point 1.999))
研究者
PD Dr. Johannes W. Dietrich, MD
Senior consultant endocrinologist
Ruhr University of Bochum