Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 11:46 AM
Study NCT ID:
NCT03363451
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2017-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate to empirical antibiotic treatment', 'timeFrame': '6 months', 'description': 'The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment'}], 'secondaryOutcomes': [{'measure': 'Non-liver transplant survival', 'timeFrame': '6 months', 'description': 'Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment'}, {'measure': 'Hospitalization time', 'timeFrame': '6 months', 'description': 'Days of hospitalization after empirical antibiotic treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Liver Disease', 'Infection']}, 'descriptionModule': {'briefSummary': "The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDecompensation of liver cirrhosis:\n\n1. ALB \\<35 g / L; A / G \\<1.0\n2. TBIL\\> 35μmol / L;\n3. ALT\\> 1 × ULN and / or AST\\> 1 × ULN\n4. PTA \\<60%\n5. Ascites or hepatic encephalopathy or esophageal variceal bleeding\n\nAcute-on-chronic liver failure:\n\n1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis\n2. onset time: \\<4 weeks\n3. Hepatic encephalopathy: with or without\n4. Coagulation: PTA ≤ 40% or INR ≥ 1.5\n5. Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L\n\nChronic liver failure:\n\n1. The basis of chronic liver disease: decompensated cirrhosis\n2. onset time: -\n3. Hepatic encephalopathy: with or without\n4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03363451', 'briefTitle': 'A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)', 'orgStudyIdInfo': {'id': 'SESLDIR study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infection Group', 'description': 'Patients with end stage liver disease with infection', 'interventionNames': ['Drug: Antibiotics']}, {'label': 'Non-infection Group', 'description': 'Patients with end stage liver disease without infection'}], 'interventions': [{'name': 'Antibiotics', 'type': 'DRUG', 'description': 'This is an observation study, no specific antibiotics will be indicated during treatment', 'armGroupLabels': ['Infection Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, Prof.', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '862883662391'}], 'facility': 'Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Infectious Disease', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}