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NCT Number: NCT07651137

Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant

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.

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Key information

Conditions

Liver Transplant Infection Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Donor-derived Infection Infections Kidney Transplant Kidney Transplant Infection Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40128

Location contact

Matteo Rinaldi, MD

CONTACT

[email protected]

+39 051 2143595

Matteo Rinaldi, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To describe the management of positive fluid cultures

    Time frame: During the post-transplant follow-up period (up to 180 days)

    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

  2. To assess graft function

    Time frame: At 180 days post-transplantation

    To assess graft function at 180 days post-transplant across the study groups

  3. To assess patient survival

    Time frame: At 180 days post-transplantation

    To assess all-cause mortality at 180 days post-transplant across the study groups

  4. To confirm donor-derived infections at a molecular level (prospective phase only)

    Time frame: During the data analysis phase (Months 31-33)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Maddalena Giannella, MD, PhD

CONTACT

[email protected]

+39 051 2143199

Matteo Rinaldi, MD

CONTACT

[email protected]

+39 051 2143595

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PREVENT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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