Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO

Recruiting

• Conditions: Organ Failure, Multiple; LIVER TRANSPLANTATION

• Registration Number: NCT06781502
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION

Detailed Description

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:

Retrospective data collection: Patients diagnosed between 01/01/2013 and the start date of the study.

Prospective data collection: Patients diagnosed after the start of the study until the end of the recruitment period (10 years).

Study Timeline

• Study Start: 2023-10-21
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2033-10
• Study Completion: 2033-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Diagnosis of acute or chronic liver disease or LT
• Age ≥ 18 years
• Obtaining informed consent

Exclusion Criteria

• no one

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiological classification of Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine	10 years	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.
Incidence of Complications in Chronic Liver Disease	10 years	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.
Hospitalization Rates	10 years	This section analyzes the hospitalization rates of patients with acute and chronic liver diseases, highlighting the frequency of hospital stays.
Number of Liver Transplantation Candidates Evaluated	10 years	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
Number of Liver Transplants Performed Annually	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Survival Rate Quantification	10 years	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
Description of Prescribed Treatments and Variations for Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine	10 years	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

Trial Locations

Locations (1)

IRCCS - Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy