NCT07651137

Brief 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). 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Liver Transplant InfectionKidney Transplant InfectionLiver TransplantKidney TransplantBacterial InfectionDonor-derived Infection

Keywords

perfusion fluidgrafttransplantationtransplant recipientsinfectionsdonor-derived infectionsliver transplantkidney transplantpreservation fluid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • To describe the management of positive fluid cultures

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

  • To assess graft function

    At 180 days post-transplantation

  • To assess patient survival

    At 180 days post-transplantation

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

    During the data analysis phase (Months 31-33)

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40128, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In the prospective phase, microorganisms isolated from preservation/perfusion fluid and recipient samples (collected as part of routine clinical practice) will be stored in the Microbiology Laboratory of IRCCS AOUBO. In cases of patients with suspected donor-derived infection, strains isolated from donor and recipient will undergo Whole Genome Sequencing to confirm or exclude donor-derived pathogen transmission.

MeSH Terms

Conditions

Bacterial InfectionsInfections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Study Officials

  • Matteo Rinaldi, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Rinaldi, MD

CONTACT

+39 051 2143595matteo.rinaldi@aosp.bo.it

Maddalena Giannella, MD, PhD

CONTACT

+39 051 2143199maddalena.giannella@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations

IT(1)