Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2848 | Other Identifier | Ethics Committee ID | |
| U1111-1122-3245 | Registry Identifier | WHO ICTRP Universal Trial Number (UTN) | |
| DRKS00003152 | Registry Identifier | DRKS (German Clinical Trials Register) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wissenschaftskommission des Universitaetsklinikums Bergmannsheil | UNKNOWN |
| Private Sponsor (Chantal C. Guilhemotonia-Urban) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis. | Diagnostic accuracy (sensitivity, specificity and AUCs of ROC analysis) of the thyroid's calculated secretory capacity (GT) for differentiation between NTIS and subclinical hyperthyroidism. | Three weeks after admission to ICU (evaluation point 1.5) and additionally on day of discharge from the hospital (evaluation point 1.999) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Critically ill patients treated at three intensive care units of the Bergmannsheil university hospitals and that comply with the eligibility criteria.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johannes W Dietrich, M.D. | Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | Principal Investigator |
| Steffen Hering, M.D. | Diabetes-Zentrum, Mathias-Spital Rheine | Study Director |
| H H Klein, M.D. | Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum | Bochum | North Rhine-Westphalia | D-44780 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18851740 | Background | 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. | |
| 23365787 |
| Label | URL |
|---|---|
| Public study site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005067 | Euthyroid Sick Syndromes |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Kryobase with serum and urine samples
| Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | Bochum | North Rhine-Westphalia | D-44789 | Germany |
| Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum | Bochum | North Rhine-Westphalia | D-44789 | Germany |
| Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | Bochum | North Rhine-Westphalia | D-44789 | Germany |
| Diabetes-Zentrum, Mathias-Spital | Rheine | North Rhine-Westphalia | D-48431 | Germany |
| Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern | Kaiserslautern | Rhineland-Palatinate | D-67655 | Germany |
| 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. |
| 26279999 | Background | Dietrich JW, Muller P, Schiedat F, Schlomicher M, Strauch J, Chatzitomaris A, Klein HH, Mugge A, Kohrle J, Rijntjes E, Lehmphul I. Nonthyroidal Illness Syndrome in Cardiac Illness Involves Elevated Concentrations of 3,5-Diiodothyronine and Correlates with Atrial Remodeling. Eur Thyroid J. 2015 Jun;4(2):129-37. doi: 10.1159/000381543. Epub 2015 May 23. |
| 27375554 | Background | Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016. |
| 28775711 | Background | Chatzitomaris A, Hoermann R, Midgley JE, Hering S, Urban A, Dietrich B, Abood A, Klein HH, Dietrich JW. Thyroid Allostasis-Adaptive Responses of Thyrotropic Feedback Control to Conditions of Strain, Stress, and Developmental Programming. Front Endocrinol (Lausanne). 2017 Jul 20;8:163. doi: 10.3389/fendo.2017.00163. eCollection 2017. |
| 29922229 | Background | Dietrich JW, Midgley JEM, Hoermann R. Editorial: "Homeostasis and Allostasis of Thyroid Function". Front Endocrinol (Lausanne). 2018 Jun 5;9:287. doi: 10.3389/fendo.2018.00287. eCollection 2018. No abstract available. |
| 33179374 | Result | Aweimer A, El-Battrawy I, Akin I, Borggrefe M, Mugge A, Patsalis PC, Urban A, Kummer M, Vasileva S, Stachon A, Hering S, Dietrich JW. Abnormal thyroid function is common in takotsubo syndrome and depends on two distinct mechanisms: results of a multicentre observational study. J Intern Med. 2021 May;289(5):675-687. doi: 10.1111/joim.13189. Epub 2020 Nov 12. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |