Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-03-02 @ 1:35 AM
Study NCT ID:
NCT06179368
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'short termoutcome', 'timeFrame': '(0 to 30 days)', 'description': 'mortality during hospitalstay'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '(0 to 30 days)', 'description': 'suchas renal affection, bleeding tendency ...etc'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Failure', 'Hypothyroidism'], 'conditions': ['Hepatic Encephalopathy', 'Hepatic Impairment', 'Hypothyroidism', 'Hepatic Failure']}, 'referencesModule': {'references': [{'pmid': '30294575', 'type': 'BACKGROUND', 'citation': 'Punekar P, Sharma AK, Jain A. A Study of Thyroid Dysfunction in Cirrhosis of Liver and Correlation with Severity of Liver Disease. Indian J Endocrinol Metab. 2018 Sep-Oct;22(5):645-650. doi: 10.4103/ijem.IJEM_25_18.'}, {'type': 'BACKGROUND', 'citation': "McCormick PA. Sherlock's Diseases of the Liver and Biliary System Textbook. Hepatic Cirrhosis. In: Dooley JS, Lok AS, Burroughs AK, Heathcote EJ, editors. 12th ed. Ch. 7. UK: Wiley-Blackwell, A John Wiley and Sons, Ltd; 2011. pp. 103-8."}]}, 'descriptionModule': {'briefSummary': 'Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase.', 'detailedDescription': 'In clinical terms, cirrhosis is described as are either "compensated" or "decompensated." Decompensation means cirrhosis complicated by one or more of the following features: jaundice, ascites, hepatic encephalopathy (HE), or bleeding varices. Ascites is the usual first sign. Hepatorenal syndrome, hyponatremia, and spontaneous bacterial peritonitis are also features of decompensation, but in these patients, ascites invariably occurs first. Compensated cirrhotic patients have none of these features.\n\nThe liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to T3 by Type 1 deiodinase.\n\nT4 and T3 regulate the basal metabolic rate of all cells, including hepatocytes, and thereby modulate hepatic function. The liver metabolizes the THS and regulates their systemic endocrine effects. Thyroid diseases may perturb liver function; liver disease modulates thyroid hormone metabolism; and a variety of systemic diseases affect both the organs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all hepatic failutre patients who will be admitted to ICU will be enrolled, and throid function will be assessed. Groupingwil be done based upon throid function', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- hepatic fauiure patients\n\nExclusion Criteria:\n\n* hypethyroid patients'}, 'identificationModule': {'nctId': 'NCT06179368', 'briefTitle': 'Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Thyoid Dysfucntion; Does it Affect the Short Term Outcome of Heptic Failure Patiens ?', 'orgStudyIdInfo': {'id': 'IRB121223'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypothroid group', 'description': 'throid fuction will be evaluated on admission of hepatic failure patients, and the hypothroid patients will be enroled in this group.', 'interventionNames': ['Diagnostic Test: hypothroidism']}, {'label': 'Euthroid group', 'description': 'throid fuction will be evaluated on admission of hepatic failure patients, and the euothroid patients will be enroled in this group.', 'interventionNames': ['Diagnostic Test: euothyroid']}], 'interventions': [{'name': 'hypothroidism', 'type': 'DIAGNOSTIC_TEST', 'description': 'throid fuction will be evaluated on admission of hepatic failure patients, and the hypothyroid patients will be enroled in this group.', 'armGroupLabels': ['Hypothroid group']}, {'name': 'euothyroid', 'type': 'DIAGNOSTIC_TEST', 'description': 'throid fuction will be evaluated on admission of hepatic failure patients, and the euothyroid patients will be enroled in this group.', 'armGroupLabels': ['Euthroid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Emad Z Kamel, M.D.', 'role': 'CONTACT', 'email': 'emadzarief@yahoo.com', 'phone': '+201007046058'}], 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}