Exhaled Volatile Organic Compounds as Potential Predictive Biomarkers of Chronic Kidney and Liver Rejection After Transplants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Volatile organic compounds after liver transplant
研究概览
简要总结
Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.
Chronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.
While acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.
Considering the recent application of the breathomic to liver and kidney disease and the difficulty in the early detection of chronic rejection after liver and kidney transplants, the analysis of the exhaled VOCs pattern could help early detection of chronic rejection allowing a prompt medical treatment.
详细描述
Kidney and liver trasplants represent very challenging lifesaving and effective surgical procedures for patients with end-stage kidney and/or liver disease.
Nowadays the short and long term success rate of kidney and liver trasplants is pretty hight. Nevertheless, transplant rejection remains one of the biggest limitations with a strong impact on patients survival.
Usually acute rejection occurs within 3 months after the transplant and is the most common cause of transplant failure and the most common indication for re-transplantation .
Chronic rejection may occur in 3 to 17% livers transplants and in 20 to 40% kidney transplants.
While acute rejection is clearly detected due to the clinical features and laboratory tools, the early identification of chronic rejection is still challenging since the clinical features are often silents and laboratory tests become suggestive when the damage due to the rejection is almost irreversible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for liver or kidney transplant
- •Written informed consent
排除标准
- •Acute liver failure
- •Acute liver and kidney rejection
- •Re-transplant
- •Pregnancy
- •Any psychiatric disease
研究组 & 干预措施
Liver/kidney transplant
The breath of patients undergoing liver or kidney transplant will be sampled and analysed
干预措施: Breath analysis (Other)
结局指标
主要结局
Volatile organic compounds after liver transplant
时间窗: 1 year
to evaluate the pattern of volatile organic compounds able to identify the onset of chronic failure/rejection after liver transplants
Volatile organic compounds in end stage liver disease
时间窗: 30 days
to evaluate the pattern of volatile organic compounds in patients elegible for liver transplant
Volatile organic compounds in end stage kidney disease
时间窗: 30 days
to evaluate the pattern of volatile organic compounds in patients elegible for kidney transplant
次要结局
未报告次要终点