Набор скоро начнётся NCT07651137

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

— Наблюдательное Liver Transplant Infection Kidney Transplant Infection Liver Transplant Kidney Transplant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Liver Transplant Infection, Kidney Transplant Infection, Liver Transplant, Kidney Transplant. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

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.

Первичные конечные точки

To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications [Срок оценки: At 30, 90, and 180 days post-transplant]

Вторичные конечные точки (4)

To describe the management of positive fluid cultures [Срок оценки: During the post-transplant follow-up period (up to 180 days)]
To assess graft function [Срок оценки: At 180 days post-transplantation]
To assess patient survival [Срок оценки: At 180 days post-transplantation]
To confirm donor-derived infections at a molecular level (prospective phase only) [Срок оценки: During the data analysis phase (Months 31-33)]

Критерии участия

Критерии включения

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