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临床试验/NCT05743751
NCT05743751尚未招募不适用

Prospective Randomized Controlled Study Normothermic Pulse Perfusion Comparing and Hypothermic Machine Perfusion in Margin Deceased Donor Kidney Transplantation

Zhang Tianyu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Rate of delayed renal function (DGF)

研究概览

简要总结

Due to the rising incidence of renal failure and the improvement of organ transplantation technology, the shortage of donor organs has become one of the main problems limiting the development of kidney transplantation. Marginal donor is one of the important ways to extend the donor pool. Normothermic mechanical perfusion (NMP) is a new generation of organ preservation technology, which can maintain the blood supply and at the same time evaluate the marginal kidney function during the organ preservation. However, the clinical effect has not been proved. Hypothermic Machine Perfusion (HMP) is the mainstream organ perfusion technology. This study aims to compare the effectiveness of NMP with the HMP.

详细描述

The main purpose of the study is to improve the utilization rate of marginal donors through normothermic perfusion, and reduce the incidence of infection, severe rejection and even graft failure caused by implantation of marginal donors. This study aims at the following aspects:

  1. To compare the effects of two methods and perfusion parameters on the quality of marginal donors: normal temperature pulse perfusion and low temperature mechanical perfusion;
  2. Explore the methods of evaluating the function of donor organs;
  3. Exploring the effects of different mechanical perfusion methods and perfusion conditions on marginal donors;
  4. The effect of broad-spectrum antibiotics on improving donor infection through different administration routes and different drug doses during perfusion and preservation.

A single-center prospective randomized controlled study was used to compare the prognosis of renal transplantation between 50 patients with normothermic pulse perfusion and 50 patients with hypothermic mechanical perfusion who were enrolled in our hospital for allograft kidney transplantation.

Assessment factors:

  1. Donor parameters: age, sex, creatinine, diabetes, cause of death, length of stay in ICU, calcification of donor renal artery (CRP expression level)
  2. Perfusion pressure, perfusion time, perfusion temperature, perfusion vessel resistance index
  3. Receptor factors: age, gender, height, weight, BMI, cause of kidney disease (hypertension, diabetes glomerulonephritis, polycystic kidney disease), dialysis time (month), dialysis type (blood/peritoneum), HLA mismatch number, smoking, diabetes, hypertension, heart disease, hyperlipidemia, anemia, complication index (CCI), ASA score (>3 or ≤ 3), operation time, number of donor renal artery branches, number of donor renal vein branches, donor creatinine, cold ischemia time (mins), and the perfusion of the transplanted kidney ( judged by the fluorescence intensity after indocyanine green injection). Laboratory results: PRA (panel-reactive antibody), blood creatinine, estimated glomerular filtration rate (eGFR), blood lactate level, postoperative urine volume. Graft loss, culture result of irrigation solution (bacteria). Sample acquisition: obtaining the blood and urine samples of the recipient and measuring the expression level of globulin A in the serum. In the process of kidney transplantation, the donor's renal artery vessel wall and the recipient's external iliac artery vessel wall were obtained. The blood vessel wall was stained with calcification, CRP to evaluate the calcification of the donor and recipient vessels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Participant and care provider were blinded to the interventions.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years old, gender unlimited
  • Volunteer to participate in this clinical trial and sign the informed consent form
  • Suffering from end-stage renal disease
  • Planned kidney transplantation
  • The expanded standard donors (ECD) were obtained
  • The expanded standard kidney donor is defined as: aged cadaver donors over 60 years old or two or three of the following conditions between 50 and 60 years old: death due to cerebrovascular disease; Hypertension; The blood creatinine level before donation was greater than 133umol/L.

排除标准

  • Active infection
  • Living donor kidney recipient
  • Acute rejection
  • Second kidney transplantation
  • Combined transplantation (combined liver and kidney, combined pancreas and kidney)
  • Patients who take other clinical trial drugs or participate in other clinical studies
  • Unable to continue the research
  • Patients who are judged by the researcher to be unsuitable for this clinical trial

结局指标

主要结局

Rate of delayed renal function (DGF)

时间窗: 1 week after surgery

At least one dialysis is required within one week after kidney transplantation

次要结局

  • Patient death(1 year follow-up)
  • Estimated glomerular filtration rate(3, 6, 12 months after surgery)
  • Rate of primary non-function (PNF)(1 months after surgery)
  • Graft survival and recipient survival(1 year follow-up)
  • Complications(within 90 days after operation)

研究者

发起方
Zhang Tianyu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhang Tianyu

Principal Investigator

China-Japan Friendship Hospital

研究点 (1)

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