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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant Infection; Kidney Transplant Infection; Liver Transplant; Bacterial Infection; Kidney Transplant; Donor-derived Infection

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 Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Maddalena Giannella, MD, PhD; Phone Number: +39 051 2143199; Email: maddalena.giannella@unibo.it
• Study Contact Backup: Name: Matteo Rinaldi, MD; Phone Number: +39 051 2143595; Email: matteo.rinaldi@aosp.bo.it

Study Locations

• Italy
  • Italy
    • Bologna, Italy, Italy, 40128
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Matteo Rinaldi, MD; Phone Number: +39 051 2143595; Email: matteo.rinaldi@aosp.bo.it
      • Principal Investigator: Matteo Rinaldi, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 30, 90, and 180 days post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	At 180 days post-transplantation
To assess patient survival	To assess all-cause mortality at 180 days post-transplant across the study groups	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)	During the data analysis phase (Months 31-33)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Matteo Rinaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: infections; transplantation; kidney transplant; graft; liver transplant; transplant recipients; perfusion fluid; donor-derived infections; preservation fluid
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections
• Other Study ID Numbers: PREVENT (Janssen Biotech Inc.); RC-2026-2802100 (Other Grant/Funding Number: Italian Ministry of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No