Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome
NCT ID: NCT00591032
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
590 participants
OBSERVATIONAL
2007-05-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stay of at least 24 hours at the ICU
Exclusion Criteria
* Hyperthyroidism that is treated with thyrostatic agents and exhibits a THS level not below the reference region
* Manifest AIDS disease
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wissenschaftskommission des Universitaetsklinikums Bergmannsheil
UNKNOWN
Private Sponsor (Chantal C. Guilhemotonia-Urban)
UNKNOWN
Ruhr University of Bochum
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
PD Dr. Johannes W. Dietrich, MD
Senior consultant endocrinologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Johannes W Dietrich, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Steffen Hering, M.D.
Role: STUDY_DIRECTOR
Diabetes-Zentrum, Mathias-Spital Rheine
H H Klein, M.D.
Role: STUDY_CHAIR
Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Public study site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2848
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1122-3245
Identifier Type: REGISTRY
Identifier Source: secondary_id
DRKS00003152
Identifier Type: REGISTRY
Identifier Source: secondary_id
2006-Innere-565
Identifier Type: -
Identifier Source: org_study_id