Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT06781502
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2033-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiological classification of Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine', 'timeFrame': '10 years', 'description': 'This indicator will evaluate the main diagnostic states and substates of patients with acute or chronic liver disease and/or liver transplantation, followed at the U.O. of Internal Medicine for serious organ failure and the Liver Transplant Program of the IRCCS AOUBO.'}, {'measure': 'Incidence of Complications in Chronic Liver Disease', 'timeFrame': '10 years', 'description': 'This measure aims to assess the incidence of complications associated with chronic liver disease in patients followed at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO.'}, {'measure': 'Hospitalization Rates', 'timeFrame': '10 years', 'description': 'This section analyzes the hospitalization rates of patients with acute and chronic liver diseases, highlighting the frequency of hospital stays.'}, {'measure': 'Number of Liver Transplantation Candidates Evaluated', 'timeFrame': '10 years', 'description': 'This measure tracks the number of patients evaluated for liver transplantation at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO'}, {'measure': 'Number of Liver Transplants Performed Annually', 'timeFrame': '10 years', 'description': 'This measure tracks the number of liver transplants performed annually at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO.'}], 'secondaryOutcomes': [{'measure': 'Description of Prescribed Treatments and Variations for Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine', 'timeFrame': '10 years', 'description': 'This measure aims to describe the prescribed treatments and any variations made for the entire population of patients with acute or chronic liver disease and/or liver transplantation, followed at the U.O. of Internal Medicine for serious organ failure and the Liver Transplant Program of the IRCCS AOUBO. Treatment data will be collected, including the specific therapies prescribed at diagnosis and during follow-up, as well as any modifications to the treatment plan based on patient response or clinical changes'}, {'measure': 'Survival Rate Quantification', 'timeFrame': '10 years', 'description': 'This measure aims to quantify survival rates for the entire population of patients with acute or chronic liver disease and/or liver transplantation, followed at the U.O. of Internal Medicine for serious organ failure and the Liver Transplant Program of the IRCCS AOUBO. Survival outcomes will be assessed starting from diagnosis, with rates measured at 1, 3, 5, and 10 years post-diagnosis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Organ Failure, Multiple', 'LIVER TRANSPLANTATION']}, 'descriptionModule': {'briefSummary': 'ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION', 'detailedDescription': 'This is an observational, spontaneous, monocentric study with structured data collection from the medical records of patients diagnosed with acute or chronic liver failure. The study will involve both retrospective and prospective data collection:\n\nRetrospective data collection: Patients diagnosed between 01/01/2013 and the start date of the study.\n\nProspective data collection: Patients diagnosed after the start of the study until the end of the recruitment period (10 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients belonging to the U.O. will be enrolled. of the Liver Transplant Program of the IRCCS University Hospital of Bologna (Internal Medicine Unit for the treatment of serious organ failure, U.O. Hepatobiliary and Transplant Surgery, Program Abdominal surgery in end organ failure and in patients with organ transplant), in which a diagnosis of acute or chronic liver disease has been made or undergoing liver transplant, starting from 01/01/2013.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute or chronic liver disease or LT\n* Age ≥ 18 years\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* no one'}, 'identificationModule': {'nctId': 'NCT06781502', 'briefTitle': 'Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO', 'orgStudyIdInfo': {'id': 'MITIGO'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Vitale, PhD, MD', 'role': 'CONTACT', 'email': 'giovanni.vitale@aosp.bo.it', 'phone': '0512144187'}], 'facility': 'IRCCS - Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Giovanni Vitale, MD', 'role': 'CONTACT', 'email': 'giovanni.vitale@aosp.bo.it', 'phone': '0512144187'}], 'overallOfficials': [{'name': 'Giovanni Vitale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}