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临床试验/NCT04225338
NCT04225338已完成不适用

Retrospective Study of Patients Undergoing Percutaneous Intervention of the Transplant Renal Artery Stenosis (TRAS Study)

Adriano Henrique Pereira Barbosa2 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2016年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
313
试验地点
2
主要终点
graft failure rate

研究概览

简要总结

Renal transplantation is the standard treatment for patients with end-stage chronic kidney disease because it is effective in reducing the morbidity and mortality. Despite of the satisfactory results, some patients evolve with graft dysfunction and refractory hypertension due to transplanted renal artery stenosis (TRAS). TRAS is the main vascular complication of patients undergoing kidney transplantation, with a reported incidence ranging 1 to 23% in the different series in the literature, depending on the definition and diagnostic techniques used, manifesting most commonly between the 3rd month and the 2nd year after transplantation.

Percutaneous intervention of TRAS is widely accepted as a viable treatment option, but there are few long-term data on patients undergoing angioplasty. The aim of this study was to evaluate long term outcomes clinical in patients with TRAS underwent to percutaneous intervention with or without stent.

详细描述

Renal transplantation is the standard treatment for patients with end-stage chronic kidney disease, as it is effective in reducing the morbidity and mortality of patients in this condition. Despite satisfactory results, some patients have graft dysfunction and difficult-to-control hypertension, with the main cause of transplanted renal artery stenosis (TRAS).

The incidence of TRAS varies from 1 to 23% in the various series in the literature, depending on the definition and diagnostic techniques used, most commonly occurring between the 3rd month and the 2nd year after transplantation. However, it may present at any time with refractory hypertension and / or graft dysfunction in the absence of rejection, ureteral obstruction or infection.

About 50% of TRAS cases occur at the anastomosis site and there seems to be no relationship with the type of anastomosis, whether end-to-end or end-to-side. TRAS is generally a consequence of clamp perfusion injury, incorrect suture technique, or fibrotic inflammatory reaction to suture material. Other factors attributed to TRAS are secondary to graft rejection, cytomegalovirus infection, and cadaveric donor graft. The last two factors are controversial in the literature. Late TRAS is related to progressive atherosclerosis.

The diagnosis of TRAS is made by clinical manifestations and / or by complementary exams. In addition to refractory hypertension, patients with TRAS may have increased serum creatinine, sudden graft deterioration and acute pulmonary edema. Color Doppler ultrasonography is the most commonly used method due to its easy access, low cost and does not require the use of contrast or radiolabels. However, its biggest limitation is the heavy reliance on operator expertise. It has a sensitivity of 87 to 94% and a specificity of 86 to 100%. TRAS is suspected when Doppler ultrasound has a peak systolic velocity (PSV) above 180 cm / s and a resistance index <0.50.

Computed tomography provides three-dimensional images that may be superior to those of selective angiography, with the advantage of not requiring arterial puncture and requiring less contrast. Nuclear magnetic resonance is even superior to tomography, with a sensitivity of 67 to 100% and specificity of 75 to 100%. However, its availability is still limited, besides presenting high costs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with clinical suspicion of transplanted renal artery stenosis.
  • patients undergoing angiography of the transplanted renal artery.
  • patients undergoing transplanted renal artery stenosis intervention with and without stent.

排除标准

  • refuses to participate in the study.
  • patients without clinical follow-up.
  • patients who did not renal transplanted at the hospital do Rim.

结局指标

主要结局

graft failure rate

时间窗: 08 years

graft failure rate at the end of follow-up

overall mortality rate

时间窗: 08 years

overall mortality rate at the end of follow-up

次要结局

  • glomerular filtration rate in mL/min/1,73 m2(01 month and 01 year)
  • systolic and diastolic pressure measurement in mmHg(01 month and 01 year)

研究者

发起方
Adriano Henrique Pereira Barbosa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Adriano Henrique Pereira Barbosa

Principal Investigator

Federal University of São Paulo

研究点 (2)

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