Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Number of Participants With Contrast Induced-Acute Kidney Injury
研究概览
简要总结
Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).
详细描述
Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.
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
- Single (Investigator)
盲法说明
Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 18 years
- •patients with stable angina pectoris
- •patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.
排除标准
- •history of severe injuries up to 2 months before intervention
- •history of surgeries up to 2 months before intervention
- •history of cancer,
- •acute inflammation during hospitalization
- •chronic autoimmunologic diseases
- •patients needing hemodialysis
- •chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2)
- •peripheral vascular disease affecting upper limbs.
结局指标
主要结局
Number of Participants With Contrast Induced-Acute Kidney Injury
时间窗: 48 to 72 hours after contrast exposure
absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
次要结局
- Number of Participants With Need of Renal Replacement Therapy(up to 7 days after contrast exposure)
- Number of Participants Who Presented Cardiogenic Shock(up to 7 days after contrast exposure)
- Death of Any Cause(up to one month after contrast exposure)
研究者
Karolina Stokfisz
Principal Investigator
Medical University of Lodz