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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maddalena Giannella, MD, PhD
- Número de teléfono: +39 051 2143199
- Correo electrónico: maddalena.giannella@unibo.it
Copia de seguridad de contactos de estudio
- Nombre: Matteo Rinaldi, MD
- Número de teléfono: +39 051 2143595
- Correo electrónico: matteo.rinaldi@aosp.bo.it
Ubicaciones de estudio
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Italy
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Bologna, Italy, Italia, 40128
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Contacto:
- Matteo Rinaldi, MD
- Número de teléfono: +39 051 2143595
- Correo electrónico: matteo.rinaldi@aosp.bo.it
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Investigador principal:
- Matteo Rinaldi, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
Periodo de tiempo: At 30, 90, and 180 days post-transplant
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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
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At 30, 90, and 180 days post-transplant
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To describe the management of positive fluid cultures
Periodo de tiempo: During the post-transplant follow-up period (up to 180 days)
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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
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During the post-transplant follow-up period (up to 180 days)
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To assess graft function
Periodo de tiempo: At 180 days post-transplantation
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To assess graft function at 180 days post-transplant across the study groups
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At 180 days post-transplantation
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To assess patient survival
Periodo de tiempo: At 180 days post-transplantation
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To assess all-cause mortality at 180 days post-transplant across the study groups
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At 180 days post-transplantation
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To confirm donor-derived infections at a molecular level (prospective phase only)
Periodo de tiempo: During the data analysis phase (Months 31-33)
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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)
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During the data analysis phase (Months 31-33)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matteo Rinaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PREVENT (Janssen Biotech Inc.)
- RC-2026-2802100 (Otro número de subvención/financiamiento: Italian Ministry of Health)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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