Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-22 @ 1:54 AM
Study NCT ID:
NCT03368066
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D000012', 'term': 'Abetalipoproteinemia'}, {'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006995', 'term': 'Hypobetalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003366', 'term': 'Cosyntropin'}], 'ancestors': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}, {'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bw8xz@hscmail.mcc.virginia.edu', 'phone': '9739436781', 'title': 'Dr. Brian Wentworth', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Excluded patients with Child Pugh A (compensated cirrhosis) given low number (4).'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Hospitalized Cirrhosis Patients', 'description': 'Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency\n\nCosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 1, 'seriousNumAtRisk': 100, 'deathsNumAffected': 25, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Patient who experienced nausea after Cosyntropin administration, resolved with IV anti-emetic therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Liver-related death', 'notes': "Death partially or completely attributed to patient's liver disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-liver-related death', 'notes': 'Death not related to underlying liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Cholesterol Esterification Deficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'A percent quantification of serum cholesterol esterification will be measured via blood draw. Low values represent deficiency in esterification, which is a surrogate measure of lecthicin-cholesterol acetyltransferase (LCAT) enzymatic deficiency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients in normal adrenal response group and 3 patients in RAI group were missing cholesterol ester percentage measurements'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Spur Cell Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'A peripheral blood smear will be obtained and assessed for presence of acanthocytes (spur cells). Spur cell anemia is defined as a serum hemoglobin \\< 10g/dL and the presence of \\>= 5% spur cells on blood smear.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients with RAI were missing peripheral smears to assess for the presence of spur cells'}, {'type': 'PRIMARY', 'title': 'Participant Transplant-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Transplant and Death are considered equivalent outcomes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Relative Adrenal Insufficiency (RAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hospitalized Cirrhosis Patients', 'description': 'Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency\n\nCosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'A baseline total cortisol level will be obtained and then patients will receive a standard-dose synthetic ACTH (250mcg of Cosyntropin) stimulation test to assess for the presence of adrenal insufficiency. RAI is defined as a change in the total cortisol level in response to the stimulation test of \\<9mcg/dL when measured 60 minutes after the Cosyntropin is administered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Low Free Cortisol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'Patients will have their free cortisol levels measured to assess for deficiency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient from normal adrenal response group was missing free cortisol data'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Liver Transplantation at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Patients who received a liver transplant within 90 days of enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Liver Transplantation at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Patients who received a liver transplant within 6 months of enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Within Index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within Hospitalization', 'description': 'Patients who died within the same hospitalization as enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died at 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Patients who died within 30 days of enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Patients who died within 90 days of enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'OG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Patients who died within 6 months of enrollment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Adrenal Response', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\> 9 micrograms/dL'}, {'id': 'FG001', 'title': 'Relative Adrenal Insufficiency', 'description': 'Delta cortisol response to 250mcg Cosyntropin \\< 9 micrograms/dL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '5 patients were excluded - 1 patient did not undergo cortisol stimulation testing due to administrative error and 4 patients had compensated cirrhosis (Child Pugh A).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hospitalized Cirrhosis Patients', 'description': 'Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency\n\nCosyntropin: Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Etiology of Cirrhosis', 'classes': [{'title': 'Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Non-alcoholic steatohepatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Hepatitis C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Cryptogenic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'If a patient had more than one etiology of cirrhosis (i.e. Alcohol and Hepatitis C) or an etiology of cirrhosis not otherwise categorized separately (i.e. autoimmune hepatitis, hemochromatosis, etc.), they were captured in the "other" category.', 'unitOfMeasure': 'Participants'}, {'title': 'Decompensation', 'classes': [{'title': 'Ascites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Hepatic Encephalopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Esophageal Varices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatocellular Carcinoma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aldosterone Antagonist Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Beta Blocker Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Midodrine Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Infection During Hospitalization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intensive Care Unit Stay During Hospitalization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Kidney Injury (AKI)', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Acute kidney injury (AKI) was defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria:\n\nStage 1: increase in creatinine 1.5-1.9 times baseline within 7 days or increase in creatinine \\>= 0.3 mg/dL within 48 hours or urine volume \\<0.5ml/kg/h for 6-12 hours.\n\nStage 2: increase in creatinine 2-2.9 times baseline within 7 days or urine volume \\<0.5ml/kg/h for \\>= 12 hours.\n\nStage 3: increase in creatinine \\>= 3.0 times baseline within 7 days or creatinine \\>= 4.0 or initiation of renal replacement therapy or urine volume \\<0.3ml/kg/h for \\>= 24 hours or anuria \\>= 12 hours.', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Arterial Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000', 'lowerLimit': '72', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sodium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000', 'lowerLimit': '132', 'upperLimit': '138'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Potassium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'BG000', 'lowerLimit': '3.6', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Model for End-Stage Liver Disease (MELD) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'description': 'The MELD Score ranges from 6 to 40, with a score of 6 reflecting none to minimal loss of liver + renal function and 40 reflecting severe liver and/or renal impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Child Pugh classification', 'classes': [{'title': 'B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Child-Pugh classification is a well-known classification system that characterizes severity of liver disease and is associated with increasing mortality as the classification increases. 5 variables are used in classifying a patient - degree of ascites, degree of hepatic encephalopathy, bilirubin level, albumin level, and the prothrombin time (or internationalized normal ratio). Class A is mild/compensated disease, Class B is decompensated disease, and Class C is severely decompensated disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Albumin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG000', 'lowerLimit': '2.4', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HDL', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Baseline Cortisol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'BG000', 'lowerLimit': '5.0', 'upperLimit': '11.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'micrograms/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Delta Cortisol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'BG000', 'lowerLimit': '7.6', 'upperLimit': '12.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'micrograms/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Free Cortisol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'micrograms/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cortisol Binding Globulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cholesterol Esters', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of esterified cholesterol', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-20', 'size': 1182606, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-07T10:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2017-11-20', 'resultsFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-08', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Cholesterol Esterification Deficiency', 'timeFrame': '24 hours', 'description': 'A percent quantification of serum cholesterol esterification will be measured via blood draw. Low values represent deficiency in esterification, which is a surrogate measure of lecthicin-cholesterol acetyltransferase (LCAT) enzymatic deficiency.'}, {'measure': 'Number of Participants With Spur Cell Anemia', 'timeFrame': '24 hours', 'description': 'A peripheral blood smear will be obtained and assessed for presence of acanthocytes (spur cells). Spur cell anemia is defined as a serum hemoglobin \\< 10g/dL and the presence of \\>= 5% spur cells on blood smear.'}, {'measure': 'Participant Transplant-Free Survival', 'timeFrame': '6 months', 'description': 'Transplant and Death are considered equivalent outcomes'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Relative Adrenal Insufficiency (RAI)', 'timeFrame': '24 hours', 'description': 'A baseline total cortisol level will be obtained and then patients will receive a standard-dose synthetic ACTH (250mcg of Cosyntropin) stimulation test to assess for the presence of adrenal insufficiency. RAI is defined as a change in the total cortisol level in response to the stimulation test of \\<9mcg/dL when measured 60 minutes after the Cosyntropin is administered.'}, {'measure': 'Number of Participants With Low Free Cortisol', 'timeFrame': '24 hours', 'description': 'Patients will have their free cortisol levels measured to assess for deficiency.'}, {'measure': 'Number of Participants Who Received Liver Transplantation at 90 Days', 'timeFrame': '90 days', 'description': 'Patients who received a liver transplant within 90 days of enrollment'}, {'measure': 'Number of Participants Who Received Liver Transplantation at 6 Months', 'timeFrame': '6 months', 'description': 'Patients who received a liver transplant within 6 months of enrollment'}, {'measure': 'Number of Participants Who Died Within Index Hospitalization', 'timeFrame': 'Within Hospitalization', 'description': 'Patients who died within the same hospitalization as enrollment'}, {'measure': 'Number of Participants Who Died at 30 Days', 'timeFrame': '30 days', 'description': 'Patients who died within 30 days of enrollment'}, {'measure': 'Number of Participants Who Died at 90 Days', 'timeFrame': '90 days', 'description': 'Patients who died within 90 days of enrollment'}, {'measure': 'Number of Participants Who Died at 6 Months', 'timeFrame': '6 months', 'description': 'Patients who died within 6 months of enrollment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Insufficiency', 'Cirrhosis', 'Spur Cell Anemia', 'Lecithin Acyltransferase Deficiency']}, 'referencesModule': {'references': [{'pmid': '22234976', 'type': 'BACKGROUND', 'citation': 'Fede G, Spadaro L, Tomaselli T, Privitera G, Germani G, Tsochatzis E, Thomas M, Bouloux PM, Burroughs AK, Purrello F. Adrenocortical dysfunction in liver disease: a systematic review. Hepatology. 2012 Apr;55(4):1282-91. doi: 10.1002/hep.25573.'}, {'pmid': '17629587', 'type': 'BACKGROUND', 'citation': "O'Beirne J, Holmes M, Agarwal B, Bouloux P, Shaw S, Patch D, Burroughs A. Adrenal insufficiency in liver disease - what is the evidence? J Hepatol. 2007 Sep;47(3):418-23. doi: 10.1016/j.jhep.2007.06.008. Epub 2007 Jun 28."}, {'pmid': '21545846', 'type': 'BACKGROUND', 'citation': "Triantos CK, Marzigie M, Fede G, Michalaki M, Giannakopoulou D, Thomopoulos K, Garcovich M, Kalafateli M, Chronis A, Kyriazopoulou V, Jelastopoulou E, Nikolopoulou V, O'Beirne J, Burroughs AK. Critical illness-related corticosteroid insufficiency in patients with cirrhosis and variceal bleeding. Clin Gastroenterol Hepatol. 2011 Jul;9(7):595-601. doi: 10.1016/j.cgh.2011.03.033. Epub 2011 Apr 8."}, {'pmid': '21056503', 'type': 'BACKGROUND', 'citation': "Fede G, Spadaro L, Tomaselli T, Privitera G, Piro S, Rabuazzo AM, Sigalas A, Xirouchakis E, O'Beirne J, Garcovich M, Tsochatzis E, Purrello F, Burroughs AK. Assessment of adrenocortical reserve in stable patients with cirrhosis. J Hepatol. 2011 Feb;54(2):243-50. doi: 10.1016/j.jhep.2010.06.034. Epub 2010 Sep 15."}, {'pmid': '23978347', 'type': 'BACKGROUND', 'citation': 'Fede G, Spadaro L, Tomaselli T, Privitera G, Scicali R, Vasianopoulou P, Thalassinos E, Martin N, Thomas M, Purrello F, Burroughs AK. Comparison of total cortisol, free cortisol, and surrogate markers of free cortisol in diagnosis of adrenal insufficiency in patients with stable cirrhosis. Clin Gastroenterol Hepatol. 2014 Mar;12(3):504-12.e8; quiz e23-4. doi: 10.1016/j.cgh.2013.08.028. Epub 2013 Aug 24.'}, {'pmid': '20739086', 'type': 'BACKGROUND', 'citation': 'Tan T, Chang L, Woodward A, McWhinney B, Galligan J, Macdonald GA, Cohen J, Venkatesh B. Characterising adrenal function using directly measured plasma free cortisol in stable severe liver disease. J Hepatol. 2010 Nov;53(5):841-8. doi: 10.1016/j.jhep.2010.05.020. Epub 2010 Jul 17.'}, {'pmid': '25078874', 'type': 'BACKGROUND', 'citation': 'Jang JY, Kim TY, Sohn JH, Lee TH, Jeong SW, Park EJ, Lee SH, Kim SG, Kim YS, Kim HS, Kim BS. Relative adrenal insufficiency in chronic liver disease: its prevalence and effects on long-term mortality. Aliment Pharmacol Ther. 2014 Oct;40(7):819-26. doi: 10.1111/apt.12891. Epub 2014 Jul 30.'}, {'pmid': '11904466', 'type': 'BACKGROUND', 'citation': 'Tamer S, Cefle K, Palanduz S, Vatansever S. Rheological properties of blood in patients with chronic liver disease. Clin Hemorheol Microcirc. 2002;26(1):9-14.'}, {'pmid': '17361026', 'type': 'BACKGROUND', 'citation': 'Tamer S, Cefle K, Gokkusu C, Ademoglu E, Ozturk S, Vatansever S, Palanduz S, Guler K. Comparison of rheological parameters in patients with post hepatitic and alcoholic cirrhosis. Clin Hemorheol Microcirc. 2007;36(3):247-52.'}, {'pmid': '7616839', 'type': 'BACKGROUND', 'citation': 'Kakimoto H, Imai Y, Kawata S, Inada M, Ito T, Matsuzawa Y. Altered lipid composition and differential changes in activities of membrane-bound enzymes of erythrocytes in hepatic cirrhosis. Metabolism. 1995 Jul;44(7):825-32. doi: 10.1016/0026-0495(95)90233-3.'}, {'pmid': '24325340', 'type': 'BACKGROUND', 'citation': 'Alexopoulou A, Vasilieva L, Kanellopoulou T, Pouriki S, Soultati A, Dourakis SP. Presence of spur cells as a highly predictive factor of mortality in patients with cirrhosis. J Gastroenterol Hepatol. 2014 Apr;29(4):830-4. doi: 10.1111/jgh.12473.'}, {'pmid': '4640953', 'type': 'BACKGROUND', 'citation': 'Cooper RA, Diloy Puray M, Lando P, Greenverg MS. An analysis of lipoproteins, bile acids, and red cell membranes associated with target cells and spur cells in patients with liver disease. J Clin Invest. 1972 Dec;51(12):3182-92. doi: 10.1172/JCI107145.'}, {'pmid': '2082907', 'type': 'BACKGROUND', 'citation': 'Miller JP. Dyslipoproteinaemia of liver disease. Baillieres Clin Endocrinol Metab. 1990 Dec;4(4):807-32. doi: 10.1016/s0950-351x(05)80080-1.'}, {'pmid': '28427335', 'type': 'BACKGROUND', 'citation': 'Kaiser T, Kinny-Koster B, Bartels M, Berg T, Scholz M, Engelmann C, Seehofer D, Becker S, Ceglarek U, Thiery J. Cholesterol esterification in plasma as a biomarker for liver function and prediction of mortality. BMC Gastroenterol. 2017 Apr 20;17(1):57. doi: 10.1186/s12876-017-0614-9.'}]}, 'descriptionModule': {'briefSummary': "The hepatoadrenal syndrome has been well described in the literature and is known to be associated with poorer outcomes in both stable and critically ill cirrhotic patients. In chronic liver disease, adrenal (and more specifically cortisol) insufficiency is thought to be a byproduct of altered lipid metabolism that results in decreased HDL production and thus decreased delivery of cholesterol to the adrenal for subsequent corticosteroid production. Studies to date have implicated lecithin-cholesterol acetyltransferase (LCAT) as the key enzyme which is deficient in some cirrhotic patients, leading to an impaired ability to esterify cholesterol and thus a loss of normal cellular functioning and membrane stability. The investigators seek to quantify this LCAT deficiency in a cohort of cirrhotic patients and demonstrate its association with various abnormal physiologies associated with chronic liver disease, including spur cell anemia, low HDL levels, and adrenal insufficiency.\n\nHospitalized cirrhotic patients at UVA that meet study eligibility criteria will be approached by a member of the study team to obtain consent for participation. If a patient agrees to become a study subject, they will have an approximate total of 35ml of blood drawn the following morning. Lab tests to be performed include: peripheral blood smear, lipid panel, free cortisol, cortisol binding globulin, serum cholesterol esters (surrogate for LCAT enzyme activity), and a standard-dose cortisol stimulation test. The latter involves blood drawn with the initial collection, administration of an intravenous 250mcg dose of synthetic ACTH, and then repeat small-volume blood draws at 30 minutes and 60 minutes later.\n\nSubjects will be classified as adrenally sufficient or insufficient on the basis of as standard-dose cortisol stimulation test. Variables of interest for comparison between the groups include MELD score, Child-Turcotte-Pugh (CTP) classification, high-density lipoprotein (HDL) levels, presence of spur cell anemia, serum cholesterol ester percentage (surrogate for LCAT enzymatic activity), cortisol binding globulin levels, and free cortisol levels. Student's t-test and Chi Square tests will be utilized to determine significance; a p \\<0.05 value will be used as our threshold for significance. If multiple factors are found to be significantly different in a univariate fashion between classification groups, a multivariate logistic regression analysis will be performed for adjusted analysis. The investigators will also seek to define any correlations between variables. Furthermore, the investigators will assess correlation between MELD score and serum cholesterol ester percentage, spur cell anemia, HDL levels, cortisol binding globulin levels, and free cortisol levels; similar correlate analysis will be done using CTP classification instead of MELD score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years\n* Diagnosis of cirrhosis\n* Admission to hospital\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Prior enrollment in study (i.e. readmission)\n* Prisoner\n* Pregnancy\n* Prednisone or Hydrocortisone use in last 24 hours'}, 'identificationModule': {'nctId': 'NCT03368066', 'briefTitle': 'Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?', 'orgStudyIdInfo': {'id': '20212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospitalized cirrhosis patients', 'description': 'Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency', 'interventionNames': ['Drug: Cosyntropin']}], 'interventions': [{'name': 'Cosyntropin', 'type': 'DRUG', 'description': 'Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency', 'armGroupLabels': ['Hospitalized cirrhosis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Zachary Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia School of Medicine, Department of Medicine, Division of Gastroenterology & Hepatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zachary Henry, MD', 'investigatorAffiliation': 'University of Virginia'}}}}