Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-04-17 @ 12:38 AM
Study NCT ID:
NCT01872767
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2013-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'ACTUAL', 'count': 522}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-23', 'studyFirstSubmitDate': '2013-04-27', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality within 1 month during ICU (Intensive Care Unit) stay.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Number of days stayed in ICU (Intensive Care Unit).', 'timeFrame': '30 days'}, {'measure': 'Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc', 'timeFrame': '30 days'}, {'measure': 'Proportion of patients with organ failure.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute on Chronic Liver Failure (ACLF),Cirrhosis,', 'Institute of Liver & Biliary Sciences (ILBS)'], 'conditions': ['Cirrhosis', 'Acute Liver Failure', 'Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': 'After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary Care Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).\n* Age \\> 18years\n\nExclusion Criteria:\n\n* Previous liver transplantation.\n* Patients who died within 8 hours of ICU (Intensive Care Unit) admission.\n* Acute liver failure\n* Lack of consent\n* Patient on steroids/ or any other immunosuppressive medication'}, 'identificationModule': {'nctId': 'NCT01872767', 'briefTitle': 'Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study', 'orgStudyIdInfo': {'id': 'ILBS-ACLF-0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cirrhotics/ Acute on chronic liver failure admitted to ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences.', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Amrish Sahney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Liver & Biliary Sciences.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}