Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT01631305
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2012-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levothyroxine for Children With Euthyroid Sick Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005067', 'term': 'Euthyroid Sick Syndromes'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Length of time in intensive care', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Ventilation days', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'Use of vasopressors', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}, {'measure': 'Thyroid hormones levels', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Euthyroid Sick Syndromes', 'Thyroxine', 'Intensive care'], 'conditions': ['Euthyroid Sick Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hospitalpediatrico.org/', 'label': 'Sinaloa Pediatric Hospital'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.', 'detailedDescription': 'Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children aged 1 month to 17 years.\n* Admitted to pediatric intensive care unit.\n* TSH and thyroid hormones below age specific levels.\n\nExclusion Criteria:\n\n* Known thyroid condition.\n* Brain death.\n* Gut conditions that contraindicate oral route.\n* Readmissions to intensive care unit.'}, 'identificationModule': {'nctId': 'NCT01631305', 'briefTitle': 'Levothyroxine for Children With Euthyroid Sick Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sinaloa Pediatric Hospital'}, 'officialTitle': 'Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.', 'orgStudyIdInfo': {'id': 'HPS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levothyroxine', 'description': '3 mcg/kg/day', 'interventionNames': ['Drug: Levothyroxine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Calcium magnesia.', 'interventionNames': ['Other: Calcium magnesia']}], 'interventions': [{'name': 'Levothyroxine', 'type': 'DRUG', 'otherNames': ['Brand: Eutirox.'], 'description': '3 mcg/kg/day', 'armGroupLabels': ['Levothyroxine']}, {'name': 'Calcium magnesia', 'type': 'OTHER', 'description': 'Placebo.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80200', 'city': 'Culiacán', 'state': 'Sinaloa', 'country': 'Mexico', 'facility': 'Sinaloa Pediatric Hospital', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}], 'overallOfficials': [{'name': 'Jesus J Martinez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sinaloa Pediatric Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinaloa Pediatric Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jesús Javier Martínez-García', 'investigatorAffiliation': 'Sinaloa Pediatric Hospital'}}}}