Overview

This trial is active, not recruiting.

Conditions euthyroid sick syndromes, non-thyroidal illness syndrome, low t3 syndrome
Sponsor Ruhr University of Bochum
Collaborator Wissenschaftskommission des Universitaetsklinikums Bergmannsheil
Start date May 2007
End date July 2013
Trial size 590 participants
Trial identifier NCT00591032, 2006-Innere-565, 2848, DRKS00003152, U1111-1122-3245

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome
Principal investigator Johannes W Dietrich, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Ruhr University of Bochum.