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

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

Study Overview

• Status: Recruiting
• Conditions: Organ Failure, Multiple; 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Giovanni Vitale, MD; Phone Number: 0512144187; Email: giovanni.vitale@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS - Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Giovanni Vitale, PhD, MD; Phone Number: 0512144187; Email: giovanni.vitale@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no one

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Giovanni Vitale, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2023
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: MITIGO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No