Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period (PREDITH)
Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases.
The expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (< 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score > 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival.
PREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：LEBOSSE Fanny, Dr
- 电话号码：+33 4 26 10 93 39
- 邮箱：fanny.lebosse@chu-lyon.fr
研究联系人备份
- 姓名：DELIGNETTE Marie Charlotte, Dr
- 电话号码：+33 4 26 10 90 70
- 邮箱：marie-charlotte.delignette@chu-lyon.fr
学习地点
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Clermont-Ferrand、法国、63100
- Department of Hepatology and Gastroenterology - CHU de Clermont Ferrand
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接触：
- Abergel Armand, Pr
- 电话号码：+33 4 73.75.05.04
- 邮箱：aabergel@chu-clermontferrand.fr
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Lyon、法国、69004
- Department of Hepatology and Gastroenterology - Hôpital de la Croix-Rousse
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接触：
- LEBOSSE Fanny, Dr
- 电话号码：+33 4 26 10 93 39
- 邮箱：fanny.lebosse@chu-lyon.fr
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接触：
- DELIGNETTE Marie-Charlotte, Dr
- 电话号码：+33 4 26 10 90 70
- 邮箱：marie-charlotte.delignette@chu-lyon.fr
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Montpellier、法国、34090
- Department of Hepatology and Gastroenterology - Hôpital Saint Eloi
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接触：
- Bedoya Jose Ursic, Dr
- 电话号码：33 4 67.33.70.62
- 邮箱：jose.ursicbedoya@chu-montpellier.fr
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接触：
- Monet Clément, Dr
- 电话号码：+33 4 67.33.02.62
- 邮箱：c-monet@chu-montpellier.fr
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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:
Patients awaiting liver transplantation for one of the following indications:
- Compensated cirrhosis complicated by hepatocellular carcinoma
- Chronically decompensated cirrhosis (recurrent gastrointestinal bleeding, refractory ascites, portopulmonary or hepatopulmonary syndrome, hepatic encephalopathy, chronic liver failure)
- Acute decompensated cirrhosis, with or without associated multiple organ failure (ACLF)
- Acute fulminant hepatitis
Final inclusion will be :
- Patients receiving LT AND
- Who provided their consent to participate during the initial enrollment visit AND
- For whom the baseline sample (during the day of the LT) was collected
Exclusion Criteria:
- Minors
- Patients under legal guardianship or conservatorship
- Pregnant or breastfeeding women
- Patients deprived of their liberty
- Patients not enrolled in the social security system
- Refusal to participate in the study
- Patients receiving immunosuppressive therapy prior to LT (with the exception of corticosteroids at a dosage of 40 mg per day for the treatment of alcoholic hepatitis)
- Patient who is a candidate for a combined organ transplant
- Patient receiving other immunomodulatory therapy (such as immune checkpoint inhibitors) prior to LT
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 |
干预/治疗 |
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Patients with severe liver disease waiting for liver transplantation (LT)
Only patients with the most frequent Liver transplantation (LT) indications will be eligible: complicated cirrhosis of hepatocellular carcinoma (HCC), acute or chronic decompensation of cirrhosis, with or without multi-visceral and fulminant hepatitis
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Samples will be collected at the finale inclusion of the day oh the LT, including one sample of Cyto-Chex BCT (4 millilitre mL) .
Same samples will also be collected after LT at days 1,3,5 and 10.
Biological data will be collected at those different times
For the creation of the biobank one samples of Ethylenediaminetetraacetic acid (EDTA) (4 millilitre (mL)), and one PAXgene® sample (2.5mL) will be collected:
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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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Predictive score for the risk of infectious complications
大体时间：Day 30
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The primary outcome measure will be the diagnostic performance of a predictive score for early post-Liver Transplant (LT) infectious complications occurring within 30 days after LT.
The predictive score will be derived from mHLA-DR levels measured at predefined time points (Day 0, Day 1, Day 3, Day 5, and Day 10 post-LT), the pre-transplant MELD score, and other clinical or laboratory variables significantly associated with infection risk.
The predic
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Day 30
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合作者和调查者
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
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