The Effect of Remote Postconditioning on Graft Function in Patients Undergoing Living-related Kidney Transplantation
2013年12月24日 更新者：Jong Hwan Lee、Samsung Medical Center
The purpose of this study is to investigate whether upper limb ischemic postconditioning can improve renal function and decrease ischemic-reperfusion injury in patients undergoing living donor kidney transplantation.
研究概览
详细说明
Ischemic reperfusion injury after kidney transplantation is a common clinical problem associated with a high morbidity and mortality.
To reduce the adverse effect of ischemic reperfusion injury after organ transplantation, various strategies including ischemic preconditioning or postconditioning.
Remote ischemic postconditioning is one of such strategies where brief ischemic reperfusion injury of one organ protects other organs from sustained ischemic reperfusion injury.
Remote ischemic postconditioning of the limb with a tourniquet is a safe and convenient method of postconditioning organs against ischemic reperfusion injury.
However, the efficacy of remote ischemic postconditioning in patients undergoing living donor kidney transplantation needs to be established.
Therefore, we investigate the efficacy of remote ischemic postconditioning of the upper limb with a tourniquet in recipients of kidney transplantation by measuring the markers of acute kidney injury.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国、135-710
- Samsung Seoul Hospital, Samsung Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects undergoing elective living donor kidney transplantation
- subjects older than 20 yrs who can give written informed consent
Exclusion Criteria:
- re-transplant recipients
- those with peripheral vascular disease affecting the upper limbs free of arteriovenous fistula
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Remote ischemic postconditioning group
Recipients receive remote ischemic postconditioning after declamping of renal artery during kidney transplantation
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Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
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无干预：Control group
Patients who have a deflated cuff placed on the upper limb free of arteriovenous fistula during the surgery
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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renal function of recipient after living-related kidney transplantation
大体时间：1 day before surgery
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serum creatinine concentration and urine output
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1 day before surgery
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renal function of recipient after living-related kidney transplantation
大体时间：at 2 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 2 h after declaming of renal artery
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renal function of recipient after living-related kidney transplantation
大体时间：at 6 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 6 h after declaming of renal artery
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renal function of recipient after living-related kidney transplantation
大体时间：at 12 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 12 h after declaming of renal artery
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renal function of recipient after living-related kidney transplantation
大体时间：at 24 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 24 h after declaming of renal artery
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renal function of recipient after living-related kidney transplantation
大体时间：at 48 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 48 h after declaming of renal artery
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renal function of recipient after living-related kidney transplantation
大体时间：at 72 h after declaming of renal artery
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serum creatinine concentration and urine output
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at 72 h after declaming of renal artery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Biomarkers of acute kidney injury
大体时间：before surgery and at 2, 6, 12 h after declaming of renal artery
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biomarkers of acute kidney injury: Plasma cystatin-C, Urine IL-18, Urine Neutrophil gelatinase-associated lipocalin (NGAL)
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before surgery and at 2, 6, 12 h after declaming of renal artery
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Hemodynamic parameters
大体时间：before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
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arterial blood pressure, heart rate, central venous pressure, pulse oximetry
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before surgery and at 2, 6, 12, 24, 48, 72 h after declaming of renal artery
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outcome of kidney transplantation
大体时间：at 72 h after declaming of renal artery
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number of acute rejection or number of delayed graft function
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at 72 h after declaming of renal artery
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postoperative hospital stay
大体时间：at postoperative day 60
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length of postoperative hospital stay (days)
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at postoperative day 60
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Jong Hwan Lee, M.D.,Ph.D.、Samsung Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2011年5月23日
首先提交符合 QC 标准的
2011年5月31日
首次发布 (估计)
2011年6月1日
研究记录更新
最后更新发布 (估计)
2013年12月25日
上次提交的符合 QC 标准的更新
2013年12月24日
最后验证
2013年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.