Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT04392258
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D054141', 'term': 'Ventricular Flutter'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013960', 'term': 'Thyroid Function Tests'}], 'ancestors': [{'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TSH response', 'timeFrame': 'three hours', 'description': 'Changes in TSH concentration after CPR compared to the value after 24 hours'}], 'secondaryOutcomes': [{'measure': 'Prognosis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Mortality dependent on pituitary thyrotropic partial function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid', 'homeostasis', 'allostasis', 'resuscitation', 'allostatic load', 'critical illness', 'TACITUS', 'NTIS', 'Circulatory arrest'], 'conditions': ['Heart Arrest', 'Ventricular Fibrillation', 'Ventricular Flutter', 'Ventricular Tachycardia']}, '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': '32087999', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33179374', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAim 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.\n\nPrimary 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.\n\nA 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.', 'detailedDescription': '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.\n\nAim 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.\n\nPrimary 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'De-identified datasets (protocol A) or patients (protocol B) admitted to an intensive care unit after cardiopulmonary resuscitation (CPR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission after cardiopulmonary resuscitation\n* Minimum age of 18 years\n* Results of TSH and peripheral thyroid hormone concentrations already available or possibility to reorder these investigations in a post-hoc manner if consent has been obtained (i. e. time interval after venipuncture within the storage period of the central laboratory)\n* Inclusion after own consent of the patient after reawakening, via custodian or independent consultant.\n\nExclusion Criteria:\n\n* Missing data on thyroid homeostasis in the first blood specimen (obtained before 3 hours after admission)\n* Traumatic brain injury\n* Persistent hints for thyroid dysfunction, not explained by non-thyroidal illness syndrome (NTIS) / euthyroid sick syndrome (ESS) / thyroid allostasis in critical illness, tumors, uremia and starvation (TACITUS) in consecutive investigations over several days after resuscitation\n* Functionally relevant thyroid or pituitary disorder, as documented in international classification of diseases (ICD) codes.\n* Exposure to radiocontrast agents less than 3 months ago\n* Therapy with amiodarone (currently or during the previous 3 years)\n* Pregnancy\n* Known thyroid disease\n* Consent not obtained within the routine storage period of the central laboratory\n* Post-hoc-exclusion if evidence for true dysfunction the the pituitary or the thyroid became available during the study period.'}, 'identificationModule': {'nctId': 'NCT04392258', 'acronym': 'Thyro-CPR', 'briefTitle': 'Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Observational and Diagnostical Study on Transient Allostatic Responses of Thyroid Function After Cardiopulmonary Resuscitation', 'orgStudyIdInfo': {'id': '19-6678-BR'}, 'secondaryIdInfos': [{'id': 'U1111-1251-7468', 'type': 'OTHER', 'domain': 'WHO Universal Trial Number (UTN)'}, {'id': 'DRKS00021695', 'type': 'REGISTRY', 'domain': 'Deutsches Register Klinischer Studien / German Clinical Trials Register (DRKS)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Status post resuscitation', 'description': 'Patients or dataset that underwent resuscitation', 'interventionNames': ['Diagnostic Test: TSH determination', 'Diagnostic Test: FT4 determination', 'Diagnostic Test: FT3 determination', 'Diagnostic Test: SPINA-GT', 'Diagnostic Test: SPINA-GD']}], 'interventions': [{'name': 'TSH determination', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['serum thyrotropin determination'], 'description': 'Determination of serum concentration of thyrotropin (TSH)', 'armGroupLabels': ['Status post resuscitation']}, {'name': 'FT4 determination', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['serum free T4 determination'], 'description': 'Determination of serum free thyroxine (FT4) concentration', 'armGroupLabels': ['Status post resuscitation']}, {'name': 'FT3 determination', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['serum free T3 determination'], 'description': 'Determination of serum free triiodothyronine (FT3) concentration', 'armGroupLabels': ['Status post resuscitation']}, {'name': 'SPINA-GT', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['GT', "Thyroid's secretory capacity", 'LOINC 82368-2', "thyroid's incretory capacity"], 'description': "Calculation of thyroid's secretory capacity (SPINA-GT)", 'armGroupLabels': ['Status post resuscitation']}, {'name': 'SPINA-GD', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['GD', 'Sum activity of peripheral deiodinases', 'LOINC 82367-4', 'deiodination capacity'], 'description': 'Calculation of total deiodinase activity (SPINA-GD)', 'armGroupLabels': ['Status post resuscitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-44789', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johannes W Dietrich, M.D.', 'role': 'CONTACT', 'email': 'johannes.w.dietrich@bergmannsheil.de', 'phone': '+49-234-302', 'phoneExt': '6400'}, {'name': 'Harald H Klein, M.D.', 'role': 'CONTACT', 'email': 'harald.klein@ruhr-uni-bochum.de', 'phone': '+49-234-302', 'phoneExt': '6400'}, {'name': 'Johannes W Dietrich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roland Köditz, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christine Fischer-Lahdo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nikolaos Rigas, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Assem Aweimer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer N Siekira', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Viktoria Stab, Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medizinische Klinik I, Universitätsklinikum Bergmannsheil, Ruhr-Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'centralContacts': [{'name': 'Johannes W Dietrich, M.D.', 'role': 'CONTACT', 'email': 'johannes.dietrich@ruhr-uni-bochum.de', 'phone': '+49-234-302', 'phoneExt': '6400'}, {'name': 'Christine Sievers', 'role': 'CONTACT', 'email': 'christine.sievers@bergmannsheil.de', 'phone': '+49-234-302', 'phoneExt': '6400'}], 'overallOfficials': [{'name': 'Johannes W Dietrich, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bergmannsheil University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing may be considered upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant endocrinologist', 'investigatorFullName': 'PD Dr. Johannes W. Dietrich, MD', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}