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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Wissenschaftskommission des Universitaetsklinikums Bergmannsheil
Private Sponsor (Chantal C. Guilhemotonia-Urban)
Information provided by (Responsible Party):
Johannes W. Dietrich, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00591032
First received: December 26, 2007
Last updated: April 5, 2016
Last verified: April 2016
  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

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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.


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. [ 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 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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:

  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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591032

Locations
Germany
Klinikum Ludwigsburg-Bietigheim
Bietigheim, BW, Germany, D-74321
Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum
Bochum, NRW, Germany, D-44780
Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, NRW, Germany, D-44789
Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
Bochum, NRW, Germany, D-44789
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
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. Klinikum Ludwigsburg-Bietigheim
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: April 5, 2016
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:
Syndrome
Euthyroid Sick Syndromes
Disease
Pathologic Processes
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 27, 2016