Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02965560
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-03', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '90 days'}, {'measure': 'incidence of multiorgan failure', 'timeFrame': '90 days'}, {'measure': 'all cause mortality', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Acute-On-Chronic Liver Failure', 'Cirrhosis and Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '34789156', 'type': 'DERIVED', 'citation': 'Wang Y, Wu F, Chen C, Xu L, Lin W, Huang C, Yang Y, Wu S, Qi J, Cao H, Li G, Hong M, Zhu H. Soluble urokinase plasminogen activator receptor is associated with short-term mortality and enhanced reactive oxygen species production in acute-on-chronic liver failure. BMC Gastroenterol. 2021 Nov 17;21(1):429. doi: 10.1186/s12876-021-02006-x.'}]}, 'descriptionModule': {'briefSummary': 'Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic inflammation and alleviate liver injury in mice model. However, there are no studies evaluating PGE2 as a predictor of early mortality.This study is designed to investigate whether plasma PGE2 and its receptors are associated with development of MOF and predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we will also measure several other potential predictive factors (C-reactive protein,severe hyponatremia, Second infections,Diabetes mellitus,High density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cohorts will be selected from Provincial General Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute-on-chronic liver failure according to Asian-Pacific Association for the Study of the Liver (APASL) diagnostic criteria\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma(HCC)\n* Portal vein thrombosis\n* Pregnancy\n* Human immunodeficiency virus (HIV)\n* Patients who had received immunomodulator,or cytotoxic/immunosuppressive therapy within at least the preceding 12 months'}, 'identificationModule': {'nctId': 'NCT02965560', 'acronym': 'PGE2', 'briefTitle': 'Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'A Study on Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure', 'orgStudyIdInfo': {'id': 'tclouds'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HC,CHB,AD,ACLF', 'description': 'HC healthy controls; CHB chronic hepatitis B; AD acute decompensated cirrhosis; ACLF acute-on-chronic liver failure.', 'interventionNames': ['Diagnostic Test: plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.']}], 'interventions': [{'name': 'plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['HC,CHB,AD,ACLF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haihong Zhu', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}