Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform
概览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- delayed graft function
概览
简要总结
This is a prospective cohort study:
- First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and kidney evaluation System based on Lifeport platform ).
- Second step: validate the new scoring system through prospective cohort study in our transplantation center and modify the scoring system if needed. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft survival and patient survival
- Step 3: Further validate the new scoring system in six other transplantation centers and developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF, AR, graft survival and patient survival
详细描述
Subjects are enrolled to collect the data of donors and recipients. Investigators also collect the data of recipients or donated organs as following: physiological and biochemical indexes, machine perfusion parameters, and the other factors effected on renal transplant outcomes. A Cox proportional hazards model and multiple linear regression analysis will be applied to examine the correlation among the univariate and multivariate. Based on the above analysis to improve the new scoring system, Lifeport work platform evaluation system and donor kidney quality evaluation system. Then, a multi-center clinical trial will be started to improve and verify the new scoring system. Finally, a donor kidney evaluation APP will be developed based on the scoring system and the database of clinical trials. An applicaiotion (APP) will be popularized the national transplant surgeons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Comply with the national donation after citizen death guideline
- •No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
- •No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
- •No activity of untreated systemic bacterial, viral or fungal infection;
- •Patients definitely identified
- •65 y old ≥Age\> = 18 years old, male or female
- •Renal transplantation first time
- •Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
- •Before the clinical trial, Patient sign informed consent voluntarily
排除标准
- •Older than 65 years old
- •2.Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive
- •3.Donor kidney cold storage time over 30 hours
- •4.Warm ischemia time over 20 minutes
- •5.Other reagents are added perfusion for regulation of donor renal function
- •1.Involved in other study.
- •2.Double organ or multi-organ transplant
- •3.A,B,O blood type-incompatible
结局指标
主要结局
delayed graft function
时间窗: 7 days after renal transplant
Transplant nephrectomy
时间窗: 1 year after reanl transplant
次要结局
- Renal dysfunction caused by Surgical complications(within the first 3 months)
- Abnormal serum creatinine(Serum creatinine did not return to the normal range within the first 30 days)
- Renal dysfunction caused by the acute rejection(within the first 3 months)
- lung infection lead to death(within the first 1 year)
研究者
Ding Xiaoming
Director of renal transplant department
First Affiliated Hospital Xi'an Jiaotong University