Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT06437067
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-25', 'studyFirstSubmitDate': '2024-05-25', 'studyFirstSubmitQcDate': '2024-05-25', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence rate of bacterial or fungal infection', 'timeFrame': '28 days and 90 days', 'description': 'incidence rate of bacterial or fungal infection'}, {'measure': 'mortality rate of bacterial or fungal infection', 'timeFrame': '28 days and 90 days', 'description': 'mortality rate of bacterial or fungal infection'}], 'secondaryOutcomes': [{'measure': 'incidence rate of complications', 'timeFrame': '28 days and 90 days', 'description': 'incidence rate of complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute-On-Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': "The subjects of this study were inpatients with ACLF who were admitted to Tongji Hospital in Wuhan from March 2023 to June 2025. After patients were enrolled, The patient's general information (gender, age, past medical history, etc.), complications (ascites, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, etc.), laboratory tests (CRP, PCT, INR, WBC, fungal/bacterial diagnostic tests, etc.), symptoms and signs at the time of infection, and at admission (D1), D4, D7, D14, D21, etc.) were recorded Save the blood separately. The patients were divided into fungal infection group, bacterial infection group and non-infection group according to the infection status after admission."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients with ACLF admitted to Tongji Hospital in Wuhan from March 2023 to June 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. TBIL ≥ 12 mg/mL and INR ≥ 1.5\n2. Chronic hepatitis B\n\nExclusion Criteria:\n\n(1) \\<18 or \\>80 years old; (2) primary hepatic or extrahepatic carcinoma; (3) with severe diseases of other organs or systems; (4) pregnancy; (5) imcomplete information'}, 'identificationModule': {'nctId': 'NCT06437067', 'briefTitle': 'Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Real-world Study on the Long-term Prognosis of Acute-on-chronic Liver Failure', 'orgStudyIdInfo': {'id': 'ACLF-I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-infection group', 'description': 'patients without bacterial or fungal infection'}, {'label': 'bacterial infection group', 'description': 'patients with bacterial infection'}, {'label': 'fungal infection group', 'description': 'patients with fungal infection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, PHD,MD', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8602783662391'}, {'name': 'Qin Ning, PHD,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tao Chen, PHD,MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Tao Chen, Professor', 'role': 'CONTACT', 'email': 'chentao_tjh@vip.sina.com', 'phone': '+8618971419301'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qin Ning', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}