Trial document





This trial has been registered retrospectively.
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  DRKS00003152

Trial Description

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Title

Approach to a quantitative follow-up of non-thyroidal illness syndrome

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Trial Acronym

AQUA FONTIS

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URL of the Trial

http://www.aqua-fontis.eu

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Brief Summary in Lay Language

AQUA FONTIS is a network of observational studies on non-thyroidal illness syndrome (NTIS), a still poorly understood condition in critical illness, where thyroid hormones are altered by an adaptation process.

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Brief Summary in Scientific Language

AQUA FONTIS is a network of unicentric, multidisciplinary, prospective cross-section and longitudinal studies that aims at the development of a more clear-cut diagnostic definition and classification of non-thyroidal illness syndrome (NTIS).

Non-thyroidal illness syndrome (NTIS), also referred to as euthyroid sick syndrome (ESS) or thyroid allostasis in critical illness, tumours, uraemia 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: allostatic central hypothyroidism (transient thyrotropic adaptation), 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.

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Organizational Data

  •   DRKS00003152
  •   2011/07/06
  •   2007/12/26
  •   yes
  •   Approved
  •   2848/06, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   U1111-1122-3245 
  •   NCT00591032  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   E07.8 -  Other specified disorders of thyroid
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Interventions/Observational Groups

  •   Observation group: Critically ill patients treated at one of three intensive care units of the Bergmannsheil university hospitals and that comply with the eligibility criteria.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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)]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2007/05/11
  •   750
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Severe illness requiring intensive care; stay of at least 24 hours at the ICU

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Exclusion Criteria

Substituted hypothyroidism or substitution in case of thyroid carcinoma; hyperthyroidism that is treated with thyrostatic agents and exhibits a TSH level not below the reference region; manifest AIDS disease; pregnancy

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Addresses

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    • Wissenschaftskommission des Universitätsklinikums Bergmannsheil
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Universitätsklinikum Bergmannsheil
    • Mr.  PD Dr. med.  Johannes W.  Dietrich 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Universitätsklinikum Bergmannsheil
    • Mr.  PD Dr. med.  Johannes W.  Dietrich 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Wissenschaftskommission des Universitätsklinikums Bergmannsheil
    • 44789  Bochum
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • AQUA-FONTIS-Verbund
    • Ms.  Chantal C.  Guilhemotonia-Urban 
    • 28201  Bremen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.