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

November 17, 2020 updated by: PD Dr. Johannes W. Dietrich, MD, Ruhr University of Bochum

Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome

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).

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, D-44780
        • Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum
      • Bochum, NRW, Germany, D-44789
        • Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
      • Bochum, NRW, Germany, D-44789
        • Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum
      • Bochum, NRW, Germany, D-44789
        • Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum
      • Rheine, NRW, Germany, D-48431
        • Diabetes-Zentrum, Mathias-Spital
    • RP
      • Kaiserslautern, RP, Germany, D-67655
        • Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
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.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 30, 2017

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-Innere-565
  • 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))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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