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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1251-7468 | Other Identifier | WHO Universal Trial Number (UTN) | |
| DRKS00021695 | Registry Identifier | Deutsches Register Klinischer Studien / German Clinical Trials Register (DRKS) |
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Time-limited adaptive responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardiopulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have occasionally been reported.
Aim of the planned study is to investigate the thyrotropic (i.e. thyroid-controlling) partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical measures of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective sub-study (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing treatment. This includes the evaluation of additional possible predictors, too.
Primary endpoint of the study is changed TSH concentration immediately after CPR compared to the TSH value 24 hours later. Secondary endpoint is the relation between thyroid-controlling pituitary function and mortality.
A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increased oxygen consumption of the heart in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.
Transient allostatic responses of thyroid function are common in the critically ill. About 70% of all patients treated on intensive care units develop a so-called non-thyroidal illness syndrome (NTIS) or TACITUS (thyroid allostasis in critical illness, tumours, uraemia and starvation), which is marked by low serum concentrations of the thyroid hormone T3 and other adaptive reactions of thyroid homeostasis. Occasionally, temporarily elevated concentrations of thyrotropin (TSH) and peripheral thyroid hormones are to be observed, especially after cardio-pulmonary resuscitation (CPR). However, the available evidence is limited, although abnormal concentrations of thyroid hormones after CPR have been reported.
Aim of the planned study is to investigate the thyrotropic partial function of the anterior pituitary lobe immediately after CPR. It is intended to evaluate statistical moments of TSH concentration and peripheral thyroid hormones in de-identified datasets (protocol A). Additionally, a prospective substudy (protocol B) aims at a more precise description of pituitary and thyroid responses by means of serial investigations in routine serum samples, both immediately after CPR and during the course of ongoing in-patient treatment. This also includes the evaluation of additional possible predictors.
Primary endpoint of the study are changed TSH concentrations immediately after CPR compared to the value 24 hours later. Secondary endpoint is the relation between thyrotropic pituitary function and mortality.
A high proportion of patients undergoing CPR will eventually receive iodinated radiocontrast media (e.g. for computed tomography or coronary angiography). This is one of the reasons why early identifying subjects at high risk for possible iodine-induced thyrotoxicosis is important. Increases oxygen consumption of myocardial tissue in hyperthyroidism is one of the reasons for high mortality in thyrotoxicosis. Therefore, accurate diagnosis of alterations in the hypothalamus-pituitary-thyroid (HPT) axis is of paramount importance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Status post resuscitation | Patients or dataset that underwent resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSH determination | Diagnostic Test | Determination of serum concentration of thyrotropin (TSH) |
|
| Measure | Description | Time Frame |
|---|---|---|
| TSH response | Changes in TSH concentration after CPR compared to the value after 24 hours | three hours |
| Measure | Description | Time Frame |
|---|---|---|
| Prognosis | Mortality dependent on pituitary thyrotropic partial function | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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De-identified datasets (protocol A) or patients (protocol B) admitted to an intensive care unit after cardiopulmonary resuscitation (CPR)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes W Dietrich, M.D. | Contact | +49-234-302 | 6400 | johannes.dietrich@ruhr-uni-bochum.de |
| Christine Sievers | Contact | +49-234-302 | 6400 | christine.sievers@bergmannsheil.de |
| Name | Affiliation | Role |
|---|---|---|
| Johannes W Dietrich, M.D. | Bergmannsheil University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum | Recruiting | Bochum | North Rhine-Westphalia | D-44789 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18851740 | Background | 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. | |
| 23365787 |
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Sharing may be considered upon reasonable request.
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Serum aliquots are stored for postponed determination of non-classical thyroid hormones including but not limited to thyronamines, 3,5-diiodothyronine (3,5-T2) and reverse T3 (rT3).
| FT4 determination | Diagnostic Test | Determination of serum free thyroxine (FT4) concentration |
|
|
| FT3 determination | Diagnostic Test | Determination of serum free triiodothyronine (FT3) concentration |
|
|
| SPINA-GT | Diagnostic Test | Calculation of thyroid's secretory capacity (SPINA-GT) |
|
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| SPINA-GD | Diagnostic Test | Calculation of total deiodinase activity (SPINA-GD) |
|
|
| 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. |
| 26279999 | Background | 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. |
| 27375554 | Background | 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. |
| 28775711 | Background | 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. |
| 32087999 | Background | Muller P, Dietrich JW, Lin T, Bejinariu A, Binnebossel S, Bergen F, Schmidt J, Muller SK, Chatzitomaris A, Kurt M, Gerguri S, Clasen L, Klein HH, Kelm M, Makimoto H. Usefulness of Serum Free Thyroxine Concentration to Predict Ventricular Arrhythmia Risk in Euthyroid Patients With Structural Heart Disease. Am J Cardiol. 2020 Apr 15;125(8):1162-1169. doi: 10.1016/j.amjcard.2020.01.019. Epub 2020 Jan 29. |
| 33179374 | Background | 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. |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| D054141 | Ventricular Flutter |
| D017180 | Tachycardia, Ventricular |
| D013959 | Thyroid Diseases |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D013960 | Thyroid Function Tests |
| ID | Term |
|---|---|
| D003940 | Diagnostic Techniques, Endocrine |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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