Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The rate of Delayed graft function
研究概览
简要总结
This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.
详细描述
In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Comply with the national DCD（donor 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 active, untreated systemic bacterial, viral or fungal infection;
- •Patients definitely identified
- •Mechanical perfusion RI (resistance index ) [0.18, 0.50]
- •Age> = 16 years old, male or female
- •First Renal transplantation
- •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 50 years old
- •Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
- •Donor kidney cold storage time over 30 hours
- •Warm ischemia time over 20 minutes
- •Other reagents are added perfusion for regulation of donor renal function
- •Double organ or multi-organ transplant
- •Blood type-incompatible
- •Patients with other malignant diseases
结局指标
主要结局
The rate of Delayed graft function
时间窗: the first week after transplant
Delayed graft function (DGF) is a common complication of renal transplantation. DGF can be diagnosed according to the three aspects below. i. Need for postoperative dialysis: Need for dialysis in the first week after transplant once hyperacute rejection, vascular and urinary tract complications and hyperkalemia are ruled out. ii. Urine output and serum creatinine: 1) Rise in serum Cr at 6-8 h post-operatively or \<300 ml of urine despite adequate volume and diuretics. 2) Urine output \<1 L in 24 h and \<25% fall in serum creatinine from baseline in first 24 h post-transplant. 3) Urine output \<75 mL/h in first 48 h or failure of serum Cr to decrease by 10% in the first 48 h. 4) Serum creatinine increases or remains unchanged or decreases \<10%/day during 3 consecutive days postoperatively. 5) Serum creatinine \>2.5mg/dL on Day 7 or need for post-transplant hemodialysis.6) Time required for the kidney to reach CrCl\>10 mL/min greater than 1 week.
次要结局
- Estimated Glomerular Filtration Rate(1 week, three months, six months, 12 months after kidney transplant)
研究者
Ding,Chenguang
PHD
First Affiliated Hospital Xi'an Jiaotong University