Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05719051
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Albumin Infusion in Inpatients With Decompensated Cirrhosis
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 564}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2023-01-08', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transplant-free survival at day 28 since enrollment', 'timeFrame': 'From enrollment (Day 1) to Day-28', 'description': 'Transplant-free survival at day 28 since enrollment'}], 'secondaryOutcomes': [{'measure': 'Changes of inflammatory markers from baseline', 'timeFrame': 'From baseline (sample collection date) to Day 7 and Day 14, respectively', 'description': 'Changes of the level of each measured inflammatory marker (IL6, IL-8, TNF-a, etc.) at Day 7 and Day 14 as compared to the baseline level.'}, {'measure': 'Cumulative incidence of nosocomial infection by day 28', 'timeFrame': 'From enrollment (Day 1) to Day-28', 'description': 'Cumulative incidence of nosocomial infection by day 28'}, {'measure': 'Cumulative incidence of SBP by day 28', 'timeFrame': 'From enrollment (Day 1) to Day-28', 'description': 'Cumulative incidence of SBP by day 28'}, {'measure': 'Cumulative incidence of AKI by day 28', 'timeFrame': 'From enrollment (Day 1) to Day-28', 'description': 'Cumulative incidence of AKI by day 28'}, {'measure': 'Cumulative incidence of ACLF by day 28', 'timeFrame': 'From enrollment (Day 1) to Day-28', 'description': 'Cumulative incidence of ACLF by day 28'}, {'measure': 'Transplant-free survival at day 90 since enrollment', 'timeFrame': 'From enrollment (Day 1) to Day-90', 'description': 'Transplant-free survival at day 90 since enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Albumin', 'decompensated cirrhosis', 'Systemic inflammation', 'Prognosis'], 'conditions': ['Decompensated Cirrhosis', 'Acute-On-Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': 'Albumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.\n\nThe purpose of this study is to compare the effects of different amount of human albumin infusion per week in patients with hospitalized decompensated cirrhosis on 28-day transplant-free survival and to further compare the alleviation of inflammation, reduction of incidence of nosocomial infection, spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), acute-on-chronic liver failure (ACLF), and 90-day transplant-free survival. This will be a multicenter, national, retrospective study. There will be no randomization in this retrospective study. All patients who meet the inclusion criteria and not the exclusion criteria will be enrolled. All identified patients who meet criteria will be given an ID number comprised of a site number and patient number.', 'detailedDescription': 'Patients with decompensated cirrhosis frequently develop various complications, be it related to salt and water retention, renal dysfunction, hepatic encephalopathy, portal hypertensive bleeds, or various infections. These lead to frequent hospital admissions, impaired quality of life, and increased morbidities and mortality.\n\nAlthough recent investigations have helped to elucidate the pathogenetic mechanisms that lead to the development of these complications, exactly how much each of these pathogenetic mechanisms contributes to the development of these complications is not clear. Among them, hypoalbuminemia has long been considered a cardinal feature of decompensated cirrhosis.\n\nHuman albumin is the main modulator of fluid distribution among the body compartments and also exerts many other biological properties unrelated to its oncotic power including antioxidation, immune modulation and anti-inflammatory effect, and endothelial stabilization as well as vascular integrity. Albumin infusion has been recommended by international guidelines after large-volume paracentesis in patients with ascites, or in spontaneous bacterial peritonitis to prevent and treat the hepatorenal syndrome. Long-term prophylactic administration of albumin to outpatients with prior history of ascites is also effective in preventing further complications and improving survival. A subsequent study suggests an anti-inflammatory effect of albumin in patients with cirrhosis; this finding suggests that infusions of albumin might increase survival by limiting systemic inflammation.\n\nThese promising data suggested a disease-modifying agent role of albumin in patients with decompensated cirrhosis. The investigators, therefore, hypothesized that albumin infusion in patients with hospitalized decompensated, even in short-term period use, could also improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.\n\nTo test these hypotheses, the investigators planned to perform retrospective analysis in two established cohorts of hospitalized decompensated cirrhosis: 1) the "RJH" cohort of decompensated cirrhosis in Ruijin Hospital enrolled between 2016 and 2018; 2) an established cohort of inpatients with cirrhosis enrolled from 23 centers in China between 2018 and 2019 (the "SONIC" study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Target population is hospitalized patients with decompensated cirrhosis. For the purpose of this study, two established prospect cohorts will be used retrospectively including the "RJH" cohort and the "SONIC" cohort. All patients in the abovementioned cohorts had at least one of the following events for inclusion: overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice.', 'genderDescription': 'Based on the ID card', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with decompensated cirrhosis nonelective admitted for overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice, etc.\n\nExclusion Criteria:\n\n1. Age below 16 or over 80 years\n2. Lactation/ Pregnancy women\n3. HIV infection\n4. Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugular intrahepatic portosystemic shunting, liver biopsy) or reexamination or multidisciplinary consultation)\n5. Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies\n6. Previous liver transplantation\n7. With previously known severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease; severe chronic pulmonary disease, psychiatric disorders)\n8. Taking immunosuppressive or anticoagulation drugs for the treatment of extra-hepatic disease.\n9. Patient' s refusal to participation\n10. Failure to provide prior informed consent or with documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent"}, 'identificationModule': {'nctId': 'NCT05719051', 'briefTitle': 'Albumin Infusion in Inpatients With Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Effect of Albumin Infusion in Patients With Decompensated Cirrhosis Hospitalized for Treatment of Complications of Liver Disease', 'orgStudyIdInfo': {'id': 'RJH-Albumin'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-dose group', 'description': 'Total Intravenous albumin infusion \\>1.5g/kg per week while hospitalization', 'interventionNames': ['Drug: Albumin infusion']}, {'label': 'Medium-dose group', 'description': 'Total Intravenous albumin infusion 1.0 to 1.5g/kg per week while hospitalization', 'interventionNames': ['Drug: Albumin infusion']}, {'label': 'Low-dose group', 'description': 'Total Intravenous albumin infusion \\<1.0g/kg per week while hospitalization', 'interventionNames': ['Drug: Albumin infusion']}], 'interventions': [{'name': 'Albumin infusion', 'type': 'DRUG', 'description': 'Albumin infusion was administrated according to the standard clinical practice', 'armGroupLabels': ['High-dose group', 'Low-dose group', 'Medium-dose group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qing Xie, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'xieqingrjh@163.com', 'phone': '86-13651804273'}, {'name': 'Zhujun Cao, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'estherlucifer@163.com', 'phone': '15216652990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qing XIe', 'investigatorAffiliation': 'Ruijin Hospital'}}}}