Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,998
- 试验地点
- 53
- 主要终点
- An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
研究概览
简要总结
The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.
The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned diagnostic coronary or peripheral artery angiography
- •CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
- •Statin naive, or not on statin treatment for at least 14 days
- •Withdrawal metformin or aminophylline for 48h before angiography
- •Total iodixanol volume
排除标准
- •Hypersensitivity to iodine-containing compounds and statins
- •Type 1 diabetes mellitus
- •Ketoacidosis
- •Lactic acidosis
- •CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
- •NYHA class IV or hemodynamic instability
- •Administration of any iodinated CM within 14 days before randomization
- •LDL-C<1.82mmol/L（70mg/dL）
- •Hepatic dysfunction (ALT 3 times greater than upper normal limit)
- •Thyreoid insufficiency
- •renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)
研究组 & 干预措施
1
perioperative rosuvastatin administration for at least 5 dosages
干预措施: rosuvastatin (Drug)
control
blank control of perioperative statin administration
干预措施: rosuvastatin (Drug)
结局指标
主要结局
An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
时间窗: 72 h
次要结局
- The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.(30 d)
研究者
Han Yaling, MD
vice president
Shenyang Northern Hospital