The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Serum creatinine level
研究概览
简要总结
This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.
详细描述
Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.
The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.
In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy
- •Normal contralateral renal function was defined as split renal function of >40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan
- •Written informed consent
排除标准
- •Peripheral vascular disease involving upper extremities or lower extremities
- •Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)
- •Hepatic failure, renal failure
结局指标
主要结局
Serum creatinine level
时间窗: Postoperative day 1
Postoperative serum creatinine levels as an index of kidney damage
次要结局
- The incidence of acute kidney injury (AKI)(Within 7 days after surgery)
- estimated glomerular filtration rate (eGFR)(2 weeks after surgery)
- Urine beta-2 microglobulin(2 weeks after surgery)
- Serum creatinine level(2 weeks after surgery)
- Urine microalbumin(2 weeks after surgery)
- Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side(90 minutes after induction of anesthesia)
- Urine creatinine level(2 weeks after surgery)
- Urine N-acetyl-beta-D-glucosaminidase(2 weeks after surgery)
- Glomerular filtration rate measured by scintigraphy(12 months after surgery)
研究者
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital