Liver Transplant InfectionPREVENTNCT07651137
Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant
An observational study of Liver Transplant Infection and Kidney Transplant Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant Infection, Kidney Transplant Infection, Liver Transplant
- How many people
- 1,400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Aug 2029
- 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 (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
Who may be able to join
- Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
- Availability of graft preservation fluid culture results
- Signed informed consent
Who cannot join
- None
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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40128
Matteo Rinaldi, MD, +39 051 2143595, matteo.rinaldi@aosp.bo.it
Matteo Rinaldi, MD
About this study
This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).
The study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).
The study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.
Read the detailed description
This study aims to analyze the clinical impact of culture results from the perfusion fluid used for the transport of transplanted organs on the development of infections in recipients, through the assessment of possible donor-derived infections. All patients who undergo liver or kidney transplantation and for whom perfusion fluid culture results are available will be enrolled, from 2021 until the start of the study (retrospective phase) and for a period of two years after study initiation (prospective phase).
The hypothesis underlying the study is that analysis of the organ perfusion fluid may, to some extent, predict the development of infections in patients undergoing liver or kidney transplantation. The study will also evaluate the frequency of perfusion fluids in which pathogens associated with a high risk of infection in the recipient are isolated; the frequency of complications in recipients; and mortality among recipients of organs with perfusion fluids containing high-risk pathogens compared with those containing low-risk pathogens or negative cultures.
During the prospective phase, strains isolated from the perfusion fluid and from recipient samples will be stored. Whenever a donor-derived infection is suspected (e.g., the same pathogen isolated from the perfusion fluid and subsequently from the recipient), strains isolated from the donor and recipient will undergo sequencing to confirm the clinical suspicion.
- Conditions
- Liver Transplant Infection, Kidney Transplant Infection, Liver Transplant, Kidney Transplant, Bacterial Infection, Donor-derived Infection
- Keywords
- perfusion fluid, graft, transplantation, transplant recipients, infections, donor-derived infections, liver transplant, kidney transplant, preservation fluid
- Medical subject headings
- Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO | Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
To evaluate the clinical impact of high-risk perfusion fluid cultures in both liver and kidney transplant recipients. This impact is defined as the frequency of bacterial/fungal donor-derived infections (confirmed by matching the specific strain isolated from the preservation fluid with the strain isolated from the recipient) and overall bacterial/fungal infections at 30, 90, and 180 days post-transplant, comparing patients with high-risk perfusion fluid cultures against those with low-risk or negative cultures
Measured: At 30, 90, and 180 days post-transplant
Secondary outcomes (4)
To describe the management of positive fluid cultures
To describe the clinical management of positive perfusion fluid culture results, specifically detailing the targeted antibiotic treatment (when administered), its duration, and the instrumental monitoring performed during follow-up
Measured: During the post-transplant follow-up period (up to 180 days)
To assess graft function
To assess graft function at 180 days post-transplant across the study groups
Measured: At 180 days post-transplantation
To assess patient survival
To assess all-cause mortality at 180 days post-transplant across the study groups
Measured: At 180 days post-transplantation
To confirm donor-derived infections at a molecular level (prospective phase only)
To store microorganisms isolated from preservation/perfusion fluid and recipient samples (collected as part of routine clinical practice) and to perform Whole Genome Sequencing on strains isolated from donor and recipient in cases of suspected donor-derived infection to confirm or rule out donor-derived pathogen transmission (prospective phase only)
Measured: During the data analysis phase (Months 31-33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant InfectionStudies 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
- 1,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Rinaldi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651137
- Sponsor's protocol ID
- PREVENT
- Other IDs
- RC-2026-2802100
- Acronym
- PREVENT
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant
- ClinicalTrials.gov ID
- NCT07651137
- Acronym / sponsor ID
- PREVENT / PREVENT
- Conditions
- Liver Transplant Infection, Kidney Transplant Infection, Liver Transplant, Kidney Transplant, Bacterial Infection, Donor-derived Infection
- Keywords
- perfusion fluid, graft, transplantation, transplant recipients, infections, donor-derived infections, liver transplant, kidney transplant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 16 Jun 2026 (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.
This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).
The study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).
The study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.
Detailed description
This study aims to analyze the clinical impact of culture results from the perfusion fluid used for the transport of transplanted organs on the development of infections in recipients, through the assessment of possible donor-derived infections. All patients who undergo liver or kidney transplantation and for whom perfusion fluid culture results are available will be enrolled, from 2021 until the start of the study (retrospective phase) and for a period of two years after study initiation (prospective phase).
The hypothesis underlying the study is that analysis of the organ perfusion fluid may, to some extent, predict the development of infections in patients undergoing liver or kidney transplantation. The study will also evaluate the frequency of perfusion fluids in which pathogens associated with a high risk of infection in the recipient are isolated; the frequency of complications in recipients; and mortality among recipients of organs with perfusion fluids containing high-risk pathogens compared with those containing low-risk pathogens or negative cultures.
During the prospective phase, strains isolated from the perfusion fluid and from recipient samples will be stored. Whenever a donor-derived infection is suspected (e.g., the same pathogen isolated from the perfusion fluid and subsequently from the recipient), strains isolated from the donor and recipient will undergo sequencing to confirm the clinical suspicion.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO | – | –Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
- Availability of graft preservation fluid culture results
- Signed informed consent
Key exclusion criteria (1 listed)
- None
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
To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
Time frame: At 30, 90, and 180 days post-transplant
To evaluate the clinical impact of high-risk perfusion fluid cultures in both liver and kidney transplant recipients. This impact is defined as the frequency of bacterial/fungal donor-derived infections (confirmed by matching the specific strain isolated from the preservation fluid with the strain isolated from the recipient) and overall bacterial/fungal infections at 30, 90, and 180 days post-transplant, comparing patients with high-risk perfusion fluid cultures against those with low-risk or negative cultures
4 secondary outcomes
To describe the management of positive fluid cultures
Time frame: During the post-transplant follow-up period (up to 180 days)
To assess graft function
Time frame: At 180 days post-transplantation
To assess patient survival
Time frame: At 180 days post-transplantation
To confirm donor-derived infections at a molecular level (prospective phase only)
Time frame: During the data analysis phase (Months 31-33)
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 16 Jun 2026.
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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.
Matteo Rinaldi, 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 Liver Transplant Infection and Kidney Transplant Infection, 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: opening soon, as of the sponsor's last update on 16 Jun 2026. 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 Matteo Rinaldi, MD (+39 051 2143595, matteo.rinaldi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications (time frame: At 30, 90, and 180 days post-transplant). 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 16 Jun 2026.