About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
To assess graft function
To assess graft function at 180 days post-transplant across the study groups
To assess patient survival
To assess all-cause mortality at 180 days post-transplant across the study groups
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)
Sponsors and contacts
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