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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Maddalena Giannella, MD, PhD
- 电话号码：+39 051 2143199
- 邮箱：maddalena.giannella@unibo.it
研究联系人备份
- 姓名：Matteo Rinaldi, MD
- 电话号码：+39 051 2143595
- 邮箱：matteo.rinaldi@aosp.bo.it
学习地点
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Italy
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Bologna、Italy、意大利、40128
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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接触：
- Matteo Rinaldi, MD
- 电话号码：+39 051 2143595
- 邮箱：matteo.rinaldi@aosp.bo.it
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首席研究员：
- Matteo Rinaldi, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate the clinical impact of high-risk perfusion fluid cultures in terms of infectious complications
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To describe the management of positive fluid cultures
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Matteo Rinaldi, MD、IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PREVENT (Janssen Biotech Inc.)
- RC-2026-2802100 (其他赠款/资助编号：Italian Ministry of Health)
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