Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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
结局指标
主要结局
To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
时间窗: At 30, 90, and 180 days post-transplant
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
次要结局
- 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))