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临床试验/NCT01289548
NCT01289548已完成不适用

Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Plasma Creatine Concentration of the Recipients

研究概览

简要总结

The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

详细描述

Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
  • Living donors
  • Compatible ABO blood type
  • PRA < 20%

排除标准

  • Re-transplant patients
  • Those with peripheral vascular disease affecting the lower limbs

结局指标

主要结局

Plasma Creatine Concentration of the Recipients

时间窗: within the first 3days after the operation

Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping

Urinary Output of the Recipients Postoperatively

时间窗: within the first 3days after the operation

Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation

Plasma Concentration of NGAL in the Recipients

时间窗: within the first 24hours after the operation

Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping

次要结局

  • Acute Rejection of Transplanted Kidney(before discharge)
  • Delayed Graft Function(before discharge)
  • Length of Postoperative Hospital Stay(before discharge)
  • Total Costs During the Hospitalization(from the admission to the discharge of the patients)
  • Urine Concentration of NAG Preoperatively in Recipients(before operation)
  • Urine Concentration of NAG Postoperatively in Recipients(within the first 24hours after the artery unclamping)
  • Urine Concentration of RBP Preoperatively in the Recipients(before the operation)
  • Urine Concentration of RBP Postoperatively in the Recipients(within the first 24hours after the artery unclamping)
  • Plasma Concentration of SOD in the Recipients(within 24hours after the operation)
  • Plasma Concentration of MDA in the Recipients(within the first 24hours after the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hua Zheng

M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Huazhong University of Science and Technology

研究点 (1)

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