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Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome

Information source: Ruhr University of Bochum
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Euthyroid Sick Syndromes; Non-thyroidal Illness Syndrome; Low T3 Syndrome

Phase: N/A

Status: Active, not recruiting

Sponsored by: Ruhr University of Bochum

Official(s) and/or principal investigator(s):
Johannes W Dietrich, M.D., Principal Investigator, Affiliation: Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Steffen Hering, M.D., Study Director, Affiliation: Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
H H Klein, M.D., Study Chair, Affiliation: Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum

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).

Clinical Details

Official title: Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis.

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.

Detailed description: Detailed Description: Non-thyroidal illness syndrome (NTIS or euthyroid sick syndrome) 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Severe illness requiring intensive care

- Stay of at least 24 hours at the ICU

Exclusion Criteria:

- 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

Locations and Contacts

Klinikum Ludwigsburg-Bietigheim, Bietigheim, BW D-74321, Germany

Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum, Bochum, NRW D-44780, Germany

Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum, Bochum, NRW D-44789, Germany

Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum, Bochum, NRW D-44789, Germany

Klinik für Innere Medizin, Evangelisches Krankenhaus Hattingen, Hattingen, NRW D-45527, Germany

Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern, Kaiserslautern, RP D-67655, Germany

Additional Information

Public study site

Related publications:

Dietrich JW, Stachon A, Antic B, Klein HH, Hering S. The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome. BMC Endocr Disord. 2008 Oct 13;8:13. doi: 10.1186/1472-6823-8-13.

Dietrich JW, Landgrafe G, Fotiadou EH. TSH and Thyrotropic Agonists: Key Actors in Thyroid Homeostasis. J Thyroid Res. 2012;2012:351864. doi: 10.1155/2012/351864. Epub 2012 Dec 30.

Starting date: May 2007
Last updated: February 12, 2015

Page last updated: August 23, 2015

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