Liver TransplantationINFE-OLTNCT03363646
Italian National Study on the Critically Ill Liver Transplant Patient With an Infection
An observational study of Liver Transplantation and Infection, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplantation, Infection, Sepsis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2018to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: liver transplant recipients
Who may be able to join
- Age> 18 aa
- Sex: Both
- written consent to participate in the study
- having been undergone to OLT in the 10 years prior to enrollment
- Infection diagnosis (any type, any localization, any agent)
- Being admitted in the ICU
- Exclusion criteria 1. Death within 72 hours of admission 2. Withdrawal of consent
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
U.O. Anestesia e Rianimazione Trapianti
Pisa, 56100
Gianni Biancofiore, +39050995409, g.biancofiore@med.unipi.it
About this study
Official title: Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient
Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern
Read the detailed description
The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs
- Conditions
- Liver Transplantation, Infection, Sepsis, Intensive Care Unit
- Medical subject headings
- Infections, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical
number and severity of infectious episodes
Measured: 18 months
microbiological
describe the type of infectious agents
Measured: 18 months
Secondary outcomes (1)
Resistance
antibiotic resistance patters of the isolates
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jul 2018
- Primary completion20 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianni Biancofiore, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363646
- Sponsor's protocol ID
- CEAVNO 56304
- Acronym
- INFE-OLT
- Status last verified
- Sep 2018
- First submitted
- 30 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient
- ClinicalTrials.gov ID
- NCT03363646
- Acronym / sponsor ID
- INFE-OLT / CEAVNO 56304
- Conditions
- Liver Transplantation, Infection, Sepsis, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 6 Dec 2017 (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.
Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern
Detailed description
The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- liver transplant recipients
Key inclusion criteria (8 listed)
- Age> 18 aa
- Sex: Both
- written consent to participate in the study
- having been undergone to OLT in the 10 years prior to enrollment
- Infection diagnosis (any type, any localization, any agent)
Key exclusion criteria (0 listed)
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
Clinical
Time frame: 18 months
number and severity of infectious episodes
microbiological
Time frame: 18 months
describe the type of infectious agents
1 secondary outcome
Resistance
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Liver Transplantation and Infection, run by Azienda Ospedaliero, Universitaria Pisana 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical (time frame: 18 months). The study lists 2 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 5 Sep 2018.