Clinical Trial: Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome
Brief Summary: 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).
Detailed Summary:
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.
Given the fact that patients with NTIS are faced with poor prognosis, several studies have been conducted in the past evaluating the question of possible treatment. However, they didn't yield unambiguous results, maybe due to the fact that these studies did not differentiate among the distinct components of NTIS.
Therefore, this study is intended to develop a clear-cut definition and classification of NTIS in order to set a foundation for future therapeutic studies.
This study recruits critically ill patients treated in medical and surgical intensive care units of the Bergmannsheil University hospitals for evaluation of integrative thyrotropic control and follow-up. From these data the correlation of i
Sponsor: Ruhr University of Bochum
Current Primary Outcome: Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis. [ Time Frame: Three weeks after admission to ICU (evaluation point 1.5) and additionally on day of discharge from the hospital (evaluation point 1.999) ]
Original Primary Outcome:
- Identification and differentiation of different functional states of thyrotropic feedback control as a starting point for rational diagnostics and therapy [ Time Frame: time of impatient treatment ]
- Definition of relevant evaluation criteria for the prognosis of affected patients [ Time Frame: one year ]
- Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis. [ Time Frame: time of impatient treatment ]
Current Secondary Outcome: 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. [ Time Frame: 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) ]
Original Secondary Outcome: 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. [ Time Frame: time of impatient treatment (may vary) ]
Information By: Ruhr University of Bochum
Dates:
Date Received: December 26, 2007
Date Started: May 2007
Date Completion: December 31, 2017
Last Updated: April 24, 2017
Last Verified: April 2017
