Organ Failure, MultipleNCT06781502
Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO
An observational study of Organ Failure, Multiple and LIVER TRANSPLANTATION, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Failure, Multiple, LIVER TRANSPLANTATION
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2023to Oct 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of acute or chronic liver disease or LT
- Age ≥ 18 years
- Obtaining informed consent
Who cannot join
- no one
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS - Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Giovanni Vitale, PhD, MD, 0512144187, giovanni.vitale@aosp.bo.it
About this study
ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION
Read the 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).
- Conditions
- Organ Failure, Multiple, LIVER TRANSPLANTATION
- Medical subject headings
- Multiple Organ Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Hospitalization Rates
This section analyzes the hospitalization rates of patients with acute and chronic liver diseases, highlighting the frequency of hospital stays.
Measured: 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
Measured: 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.
Measured: 10 years
Secondary outcomes (2)
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
Measured: 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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start21 Oct 2023
- Primary completionOct 2033 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Failure, MultipleStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Vitale, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781502
- Sponsor's protocol ID
- MITIGO
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO
- ClinicalTrials.gov ID
- NCT06781502
- Acronym / sponsor ID
- MITIGO
- Conditions
- Organ Failure, Multiple, LIVER TRANSPLANTATION
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosis of acute or chronic liver disease or LT
- Age ≥ 18 years
- Obtaining informed consent
Key exclusion criteria (1 listed)
- no one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological classification of Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Description of Prescribed Treatments and Variations for Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine
Time frame: 10 years
Survival Rate Quantification
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Vitale, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Failure, Multiple and LIVER TRANSPLANTATION, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Vitale, MD (0512144187, giovanni.vitale@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological classification of Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.