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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Maddalena Giannella, MD, PhD
- Номер телефона: +39 051 2143199
- Электронная почта: maddalena.giannella@unibo.it
Учебное резервное копирование контактов
- Имя: Matteo Rinaldi, MD
- Номер телефона: +39 051 2143595
- Электронная почта: matteo.rinaldi@aosp.bo.it
Места учебы
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Italy
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Bologna, Italy, Италия, 40128
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Контакт:
- Matteo Rinaldi, MD
- Номер телефона: +39 051 2143595
- Электронная почта: matteo.rinaldi@aosp.bo.it
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Главный следователь:
- Matteo Rinaldi, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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To describe the management of positive fluid cultures
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Главный следователь: Matteo Rinaldi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PREVENT (Janssen Biotech Inc.)
- RC-2026-2802100 (Другой номер гранта/финансирования: Italian Ministry of Health)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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