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Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome
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 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: 1. central hypothyroidism (transient thyrotropic insufficiency) 2. impaired protein binding of thyroid hormones and 3. 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 individual prognosis with laboratory-defined components of NTIS will be determined. This project is intended to: 1. deliver a prognostical aid by providing a differentiated classification, 2. to contribute to a standardised, rational and inexpensive diagnostical procedure and 3. to lay the foundation for future therapeutic trials by identifying subgroups that may benefit from therapy.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum
Bochum, North Rhine-Westphalia, Germany
Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany
Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany
Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, North Rhine-Westphalia, Germany
Diabetes-Zentrum, Mathias-Spital
Rheine, North Rhine-Westphalia, Germany
Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, Rhineland-Palatinate, Germany
Start Date
May 1, 2007
Primary Completion Date
November 30, 2017
Completion Date
December 31, 2020
Last Updated
November 19, 2020
590
ACTUAL participants
Lead Sponsor
Ruhr University of Bochum
Collaborators
NCT04112316
NCT04806672
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT03085615