Delayed CNI-based Immunosuppression With Advagraf After MELD-based Liver Transplantation (IMUTECT)
Effect of Delayed CNI-based Immunosuppression With Advagraf on Liver Function After MELD-based Liver Transplantation
研究概览
地位
条件
详细说明
The MELD-score (model of end stage liver disease) was designed to estimate the prognosis after TIPS (transjugular intrahepatic porto-systemic shunt). Nowadays it is the key-score for patients awaiting a liver graft and consists of serum-creatinine, serum-bilirubine and the INR-ratio with values between 6-40. The MELD-based liver allocation follows the sickest patient first strategy which significantly decreased outcome after liver transplantation (LTx) in Germany. There is evidence that the immune competence of very sick patients is decreased. Monocytic HLA-DR status is a marker for the function of the immune system. A reduced monocytic HLA-DR expression is indicative for a suppressed immune system.
Blood levels of Advagraf are slowly increased during the first week until the aimed tacrolimus trough levels are reached. Since therapeutic tacrolimus trough levels are reached not before the end of the first week after transplantation this is a concept for prolonged-release immunosuppression.
We assume, that high-MELD patients (MELD >20) undergoing LTx are immunosuppressed per se. Thus prolonged-release low-dose immunosuppression with Advagraf would decrease both- infection rate (CMV-reactivation, wound infection urinary tract infections, pneumonia, etc.) and side effects of immunosuppression. The immune capacity of patients will be determined by the measurement of monocytic HLA-DR status. To ensure that graft function is not impaired due to rejection episodes, liver function will be determined with the LiMAx-test, a routine procedure in our institution. After 13-C-Methacetin is given to the patient, it is metabolized to paracetamol and 13CO2 by the enzyme CYP1A2 which is localized in hepatocytes. The 13CO2/12CO2 ratio in the exhaled air correlates with liver function.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
-
Heidelberg、德国、69120
- 招聘中
- University Surgical Clinic
-
接触:
- Peter Schemmer, Prof.
- 电话号码:+4962215636500
- 邮箱:Peter.schemmer@med.uni-Heidelberg.de
-
接触:
- Daniela Hall
- 电话号码:+4962215636805
- 邮箱:Daniela.hall@med.uni-Heidelberg.de
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- age >18, <65
- first liver transplantation
- Immunosuppression with Advagraf, MMF, corticosteroid
- surgery and postoperative treatment at the department for general-, visceral- and transplantation surgery
Exclusion Criteria:
- missing informed consent
- re-transplantation
- acute infection: CMV (pp65 positive), pneumonia, urinary tract infection, wound infection, reactivation of Hepatitis B/C
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 |
---|
Advagraf-based immunosuppression
50 patients after liver transplantation (25 with a MELD-score ≤20 and 25 patients with a MELD-score >20) under CNI-based immunosuppression with Advagraf
|
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 |
---|---|---|
infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia)
大体时间:1-year follow-up per patient
|
clinical visit: infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia)
|
1-year follow-up per patient
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
liver function (LiMAx)
大体时间:one week
|
LiMAx test before liver transplantation, and on postoperative days 1, 3, 7
|
one week
|
HLA-DR status
大体时间:one week
|
HLA-DR status will be measured before liver transplantation and on postoperative days 3, 5, 7.
|
one week
|
合作者和调查者
调查人员
- 首席研究员:Peter Schemmer, Prof.、University Hospital Heidelberg
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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
- IMUTECT2013-01
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.