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

NCT00591032 | Unknown DMC

• 4 other identifiers: 2006-Innere-5652848U1111-1122-3245DRKS00003152
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Euthyroid Sick Syndromes; Non-thyroidal Illness Syndrome; Low T3 Syndrome; TACITUS

Keywords

Critical illness; Euthyroid sick syndromes; Intensive care; Non-thyroidal illness syndrome; Low-T3 syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients treated at three intensive care units of the Bergmannsheil university hospitals and that comply with the eligibility criteria.

You may qualify if:

• Severe illness requiring intensive care
• Stay of at least 24 hours at the ICU

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Wissenschaftskommission des Universitaetsklinikums Bergmannsheil: collaborator
• Private Sponsor (Chantal C. Guilhemotonia-Urban): collaborator

Study Sites (6)

Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum

Bochum, North Rhine-Westphalia, D-44780, Germany

Location

Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum

Bochum, North Rhine-Westphalia, D-44789, Germany

Location

Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, D-44789, Germany

Location

Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum

Bochum, North Rhine-Westphalia, D-44789, Germany

Location

Diabetes-Zentrum, Mathias-Spital

Rheine, North Rhine-Westphalia, D-48431, Germany

Location

Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, Rhineland-Palatinate, D-67655, Germany

Location

Related Publications (7)

• 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.

  PMID: 18851740 BACKGROUND

• 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.

  PMID: 23365787 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.

  PMID: 26279999 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.

  PMID: 27375554 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.

  PMID: 28775711 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.

  PMID: 29922229 BACKGROUND

• 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.

  PMID: 33179374 RESULT

Related Links

• Public study site

Biospecimen

Retention: SAMPLES WITHOUT DNA

Kryobase with serum and urine samples

MeSH Terms

Conditions

Euthyroid Sick Syndromes; Critical Illness

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant endocrinologist

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2007
• Primary Completion: November 30, 2017
• Study Completion: December 31, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

DE (6)