Official Title: “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 Type: Observational

Study Design: Cohort, Prospective

Detailed Description:

Non-thyroidal illness syndrome (NTIS or euthyroid sick syndrome) 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.

Arms, Groups and Cohorts in this Clinical Trial

• : H
  • Patients with hypothalamic-pituitary dysfunction or adaptation
• : P
  • Patients with impaired protein binding
• : D
  • Persons with reduced conversion of T4 to T3

Primary Measures

• Identification and differentiation of different functional states of thyrotropic feedback control as a starting point for rational diagnostics and therapy
  • Time Frame: time of impatient treatment
    Safety Issue?: No
• Definition of relevant evaluation criteria for the prognosis of affected patients
  • Time Frame: one year
    Safety Issue?: No
• Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis.
  • Time Frame: time of impatient treatment
    Safety Issue?: No

Secondary 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: time of impatient treatment (may vary)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ruhr University of Bochum

Overall Clinical Trial Officials and Contacts

Johannes W Dietrich, M.D. Principal Investigator Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum  

Overall Contact: Johannes W Dietrich, M.D. +49-234-302 johannes.w.dietrich@bergmannsheil.de

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00591032

Study ID Number: 2006-Innere-565-I

ClinicalTrials.gov Identifier: NCT00591032

Health Authority: Germany: Ärztekammer Westfalen-Lippe

Public study site