Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of CI-AKI
研究概览
简要总结
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.
详细描述
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed written consent
- •All of the following:
- •Known diagnosis of Type 2 diabetes
- •NSTEMI, unstable or stable angina
- •Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
- •eGFR < 60 mls/min or ACR > 300 mg/dl
排除标准
- •decompensated heart failure in the preceding 6 months
- •patients with underlying end stage renal disease on maintenance dialysis
- •recent (in the last 3 months) cerebrovascular disease
- •chronic liver disease
- •chronic obstructive pulmonary disease
- •gastrointestinal bleeding
- •acute or chronic infection or malignancy
研究组 & 干预措施
Remote Ischemic Preconditioning
Patients treated with Remote Ischemic Preconditioning
干预措施: Remote ischemic preconditioning (Procedure)
Sham ischemic preconditioning
Patients treated with sham ischemic preconditioning
干预措施: Sham ischemic preconditioning (Procedure)
结局指标
主要结局
Incidence of CI-AKI
时间窗: 48 hours
defined as a creatinine rise of ≥ 25% or an increase of \> 0.5mg/dl from baseline within 48 hours after contrast exposure
次要结局
- Relative change in NGAL levels from baseline(24 hours)
- Absolute change in NGAL levels from baseline(24 hours)
- Relative change in serum creatinine from baseline(72 hours)
研究者
Prof Eun-Seok Shin, MD. PhD.
Interventional Cardiologist MD. PhD.
Ulsan University Hospital
