Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT03157466
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline neuromechanical efficiency (obtained immediately before starting thyroid hormone therapy) at 3, 6, and 24 hours', 'timeFrame': '24 hours (study points at 3, 6, and 24 hours)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Diseases', 'Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '31015389', 'type': 'DERIVED', 'citation': 'Bello G, Spinazzola G, Giammatteo V, Montini L, De Pascale G, Bisanti A, Annetta MG, Troiani E, Bianchi A, Pontecorvi A, Pennisi MA, Conti G, Antonelli M. Effects of Thyroid Hormone Treatment on Diaphragmatic Efficiency in Mechanically Ventilated Subjects With Nonthyroidal Illness Syndrome. Respir Care. 2019 Oct;64(10):1199-1207. doi: 10.4187/respcare.06770. Epub 2019 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'Although it is now recognized that a variety of respiratory abnormalities, such as diaphragmatic dysfunction, can be present in primary hypothyroidism and reverse with adequate hormone treatment, the role of thyroid hormone replacement therapy on respiratory system in patients with the nonthyroidal illness syndrome (NTIS) remains to be clarified. The NTIS has been found to be an independent risk factor for prolonged (\\> 13 days) mechanical ventilation. It is unclear, however, whether the NTIS is only a biochemical prognostic marker or it actually contributes to the development and progression of respiratory failure.\n\nThe aim of this study will be to assess respiratory muscle function after thyroid hormone substitution therapy in mechanically ventilated patients with the NTIS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the intensive care unit and mechanically ventilated for more than 48 hours who fail weaining from ventilator and with a diagnosis of nonthyroidal illness syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under mechanical ventilation for more than 48 hours who experience a spontaneous breathing trial and have a diagnosis of nonthyroidal illness syndrome\n\nExclusion Criteria:\n\n* • age \\<18 yr;\n\n * pregnancy or estro-progestinic therapy;\n * tracheostomy;\n * neurological or neuromuscular pathology and/or known phrenic nerve dysfunction;\n * previously diagnosed intrinsic thyroid disease; known or suspected pituitary-hypothalamic disease;\n * severe obesity;\n * ischemic cardiopathy; complex ventricular arrhythmias;\n * serum cortisol level below 80 ng/ml; renal or hepatic failure (respectively, creatininemia ≥ 3.5 mg/dL and bilirubinemia ≥ 6.0 mg/dL);\n * transfusion of plasma within 48 h prior to thyroid hormone assessment; use of amiodarone in the previous 8 weeks;\n * use of iodine contrast agents in the previous 8 weeks;\n * hemodialysis;\n * expected poor outcomes'}, 'identificationModule': {'nctId': 'NCT03157466', 'briefTitle': 'Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Diaphragmatic Efficiency After Thyroid Hormone Replacement Therapy in Ventilated Patients With the Nonthyroidal Illness Syndrome: a Physiological Study', 'orgStudyIdInfo': {'id': '002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'BELLO GIUSEPPE', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}