跳至主要内容
临床试验/NCT02329444
NCT02329444已完成不适用

Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention

Ulsan University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年8月最近更新:
适应症
干预措施

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

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

Experimental

Patients treated with Remote Ischemic Preconditioning

干预措施: Remote ischemic preconditioning (Procedure)

Sham ischemic preconditioning

Active Comparator

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

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

Prof Eun-Seok Shin, MD. PhD.

Interventional Cardiologist MD. PhD.

Ulsan University Hospital

研究点 (2)

Loading locations...

相似试验