Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome (AQUA FONTIS)
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Purpose
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).
| Condition |
|---|
|
Euthyroid Sick Syndromes Non-thyroidal Illness Syndrome Low T3 Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome |
- 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) ] [ Designated as safety issue: No ]Diagnostic accuracy (sensitivity, specificity and AUCs of ROC analysis) of the thyroid's calculated secretory capacity (GT) for differentiation between NTIS and subclinical hyperthyroidism.
- 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) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Kryobase with serum and urine samples
| Enrollment: | 590 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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:
- 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 individual prognosis with laboratory-defined components of NTIS will be determined.
This project is intended to:
- deliver a prognostical aid by providing a differentiated classification,
- to contribute to a standardised, rational and inexpensive diagnostical procedure and
- to lay the foundation for future therapeutic trials by identifying subgroups that may benefit from therapy.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Critically ill patients treated at three intensive care units of the Bergmannsheil university hospitals and that comply with the eligibility 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
Contacts and Locations| Germany | |
| Klinikum Ludwigsburg-Bietigheim | |
| Bietigheim, BW, Germany, D-74321 | |
| Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | |
| Bochum, NRW, Germany, D-44789 | |
| Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | |
| Bochum, NRW, Germany, D-44789 | |
| Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum | |
| Bochum, NRW, Germany, D-44780 | |
| Klinik für Innere Medizin, Evangelisches Krankenhaus Hattingen | |
| Hattingen, NRW, Germany, D-45527 | |
| Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern | |
| Kaiserslautern, RP, Germany, D-67655 | |
| Principal Investigator: | Johannes W Dietrich, M.D. | Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum |
| Study Director: | Steffen Hering, M.D. | Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum |
| Study Chair: | H H Klein, M.D. | Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum |
More Information
Additional Information:
Publications:
| Responsible Party: | Johannes W. Dietrich, Senior consultant endocrinologist, Ruhr University of Bochum |
| ClinicalTrials.gov Identifier: | NCT00591032 History of Changes |
| Other Study ID Numbers: | 2006-Innere-565, 2848, U1111-1122-3245, DRKS00003152 |
| Study First Received: | December 26, 2007 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Germany: Ärztekammer Westfalen-Lippe Germany: Ethics Commission of the Ruhr-University of Bochum Germany: The Ministry of Work, Health and Social Affairs of the State North Rhine-Westphalia |
Keywords provided by Ruhr University of Bochum:
|
Critical illness Euthyroid sick syndromes Intensive care Non-thyroidal illness syndrome Low-T3 syndrome |
Additional relevant MeSH terms:
|
Euthyroid Sick Syndromes Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013