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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00591032

Collaborator

Wissenschaftskommission des Universitaetsklinikums Bergmannsheil (Other), Private Sponsor (Chantal C. Guilhemotonia-Urban) (Other)

590

Enrollment

Locations

164

Duration (Months)

98.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Euthyroid Sick Syndromes Non-thyroidal Illness Syndrome Low T3 Syndrome TACITUS

Detailed Description

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:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

590 participants

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Nov 30, 2017

Anticipated Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis. [Three weeks after admission to ICU (evaluation point 1.5) and additionally on day of discharge from the hospital (evaluation point 1.999)]
Diagnostic accuracy (sensitivity, specificity and AUCs of ROC analysis) of the thyroid's calculated secretory capacity (GT) for differentiation between NTIS and subclinical hyperthyroidism.

Secondary Outcome Measures

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

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum	Bochum	NRW	Germany	D-44780
2	Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum	Bochum	NRW	Germany	D-44789
3	Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum	Bochum	NRW	Germany	D-44789
4	Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum	Bochum	NRW	Germany	D-44789
5	Diabetes-Zentrum, Mathias-Spital	Rheine	NRW	Germany	D-48431
6	Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern	Kaiserslautern	RP	Germany	D-67655

Sponsors and Collaborators

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

Investigators

Principal Investigator: Johannes W Dietrich, M.D., Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Study Director: Steffen Hering, M.D., Diabetes-Zentrum, Mathias-Spital Rheine
Study Chair: H H Klein, M.D., Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum