Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-27 @ 4:39 PM
Study NCT ID:
NCT00591032
Status:
UNKNOWN
Last Update Posted:
2020-11-19
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005067', 'term': 'Euthyroid Sick Syndromes'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Kryobase with serum and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 590}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the significance of an innovative physiological index approach (SPINA) in differential diagnosis between NTIS and latent thyrotoxicosis.', 'timeFrame': 'Three weeks after admission to ICU (evaluation point 1.5) and additionally on day of discharge from the hospital (evaluation point 1.999)', 'description': "Diagnostic accuracy (sensitivity, specificity and AUCs of ROC analysis) of the thyroid's calculated secretory capacity (GT) for differentiation between NTIS and subclinical hyperthyroidism."}], 'secondaryOutcomes': [{'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.', 'timeFrame': '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)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Critical illness', 'Euthyroid sick syndromes', 'Intensive care', 'Non-thyroidal illness syndrome', 'Low-T3 syndrome'], 'conditions': ['Euthyroid Sick Syndromes', 'Non-thyroidal Illness Syndrome', 'Low T3 Syndrome', 'TACITUS']}, 'referencesModule': {'references': [{'pmid': '18851740', 'type': 'BACKGROUND', 'citation': 'Dietrich JW, Stachon A, Antic B, Klein HH, Hering S. The AQUA-FONTIS study: protocol of a multidisciplinary, cross-sectional and prospective longitudinal study for developing standardized diagnostics and classification of non-thyroidal illness syndrome. BMC Endocr Disord. 2008 Oct 13;8:13. doi: 10.1186/1472-6823-8-13.'}, {'pmid': '23365787', 'type': 'BACKGROUND', 'citation': 'Dietrich JW, Landgrafe G, Fotiadou EH. TSH and Thyrotropic Agonists: Key Actors in Thyroid Homeostasis. J Thyroid Res. 2012;2012:351864. doi: 10.1155/2012/351864. Epub 2012 Dec 30.'}, {'pmid': '26279999', 'type': 'BACKGROUND', 'citation': 'Dietrich JW, Muller P, Schiedat F, Schlomicher M, Strauch J, Chatzitomaris A, Klein HH, Mugge A, Kohrle J, Rijntjes E, Lehmphul I. Nonthyroidal Illness Syndrome in Cardiac Illness Involves Elevated Concentrations of 3,5-Diiodothyronine and Correlates with Atrial Remodeling. Eur Thyroid J. 2015 Jun;4(2):129-37. doi: 10.1159/000381543. Epub 2015 May 23.'}, {'pmid': '27375554', 'type': 'BACKGROUND', 'citation': 'Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016.'}, {'pmid': '28775711', 'type': 'BACKGROUND', 'citation': 'Chatzitomaris A, Hoermann R, Midgley JE, Hering S, Urban A, Dietrich B, Abood A, Klein HH, Dietrich JW. Thyroid Allostasis-Adaptive Responses of Thyrotropic Feedback Control to Conditions of Strain, Stress, and Developmental Programming. Front Endocrinol (Lausanne). 2017 Jul 20;8:163. doi: 10.3389/fendo.2017.00163. eCollection 2017.'}, {'pmid': '29922229', 'type': 'BACKGROUND', 'citation': 'Dietrich JW, Midgley JEM, Hoermann R. Editorial: "Homeostasis and Allostasis of Thyroid Function". Front Endocrinol (Lausanne). 2018 Jun 5;9:287. doi: 10.3389/fendo.2018.00287. eCollection 2018. No abstract available.'}, {'pmid': '33179374', 'type': 'RESULT', 'citation': 'Aweimer A, El-Battrawy I, Akin I, Borggrefe M, Mugge A, Patsalis PC, Urban A, Kummer M, Vasileva S, Stachon A, Hering S, Dietrich JW. Abnormal thyroid function is common in takotsubo syndrome and depends on two distinct mechanisms: results of a multicentre observational study. J Intern Med. 2021 May;289(5):675-687. doi: 10.1111/joim.13189. Epub 2020 Nov 12.'}], 'seeAlsoLinks': [{'url': 'http://www.aqua-fontis.eu', 'label': 'Public study site'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "Detailed Description:\n\nNon-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.\n\nNTIS is characterised by three components that may occur single or in combination:\n\n1. central hypothyroidism (transient thyrotropic insufficiency)\n2. impaired protein binding of thyroid hormones and\n3. reduced formation of T3 and increased conversion to rT3 (low-T3-syndrome).\n\nDespite 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.\n\nGiven 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.\n\nTherefore, this study is intended to develop a clear-cut definition and classification of NTIS in order to set a foundation for future therapeutic studies.\n\nThis 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.\n\nThis project is intended to:\n\n1. deliver a prognostical aid by providing a differentiated classification,\n2. to contribute to a standardised, rational and inexpensive diagnostical procedure and\n3. to lay the foundation for future therapeutic trials by identifying subgroups that may benefit from therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients treated at three intensive care units of the Bergmannsheil university hospitals and that comply with the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe illness requiring intensive care\n* Stay of at least 24 hours at the ICU\n\nExclusion Criteria:\n\n* Substituted hypothyroidism or substitution in case of thyroid carcinoma\n* Hyperthyroidism that is treated with thyrostatic agents and exhibits a THS level not below the reference region\n* Manifest AIDS disease'}, 'identificationModule': {'nctId': 'NCT00591032', 'acronym': 'AQUA FONTIS', 'briefTitle': 'Approach to a Quantitative Follow-up of Non-thyroidal Illness Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Development of Rational and Standardized Diagnostics and Staging for a Differentiated Risk Stratification of Non-thyroidal Illness Syndrome', 'orgStudyIdInfo': {'id': '2006-Innere-565'}, 'secondaryIdInfos': [{'id': '2848', 'type': 'OTHER', 'domain': 'Ethics Committee ID'}, {'id': 'U1111-1122-3245', 'type': 'REGISTRY', 'domain': 'WHO ICTRP Universal Trial Number (UTN)'}, {'id': 'DRKS00003152', 'type': 'REGISTRY', 'domain': 'DRKS (German Clinical Trials Register)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-44780', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department for medical informatics, biometry and epidemiology, Ruhr-University of Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-44789', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Institute of Clinical Chemistry, Transfusion and Laboratory Medicine, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-44789', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Medical Hospital II, Bergmannsheil University Hospitals, Ruhr University of Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-44789', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-48431', 'city': 'Rheine', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Diabetes-Zentrum, Mathias-Spital', 'geoPoint': {'lat': 52.28509, 'lon': 7.44055}}, {'zip': 'D-67655', 'city': 'Kaiserslautern', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Abteilung für Laboratoriums- und Transfusionsmedizin, Westpfalz-Klinikum Kaiserslautern', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}], 'overallOfficials': [{'name': 'Johannes W Dietrich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum'}, {'name': 'Steffen Hering, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diabetes-Zentrum, Mathias-Spital Rheine'}, {'name': 'H H Klein, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wissenschaftskommission des Universitaetsklinikums Bergmannsheil', 'class': 'UNKNOWN'}, {'name': 'Private Sponsor (Chantal C. Guilhemotonia-Urban)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant endocrinologist', 'investigatorFullName': 'PD Dr. Johannes W. Dietrich, MD', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}