Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Contrast-induced nephropathy
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 nephropathy (CIN). Major risk factors for CIN 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 berberine treatment during and after the perioperative period would reduce the risk of CIN in a high-risk population of patients with both DM and CKD undergoing coronary angiography or noncoronary angiography, and 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Planned diagnostic coronary or peripheral artery angiography
- •Type 2 diabetes mellitus
- •CKD stages ≥2
- •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 berberine
- •Ketoacidosis
- •Lactic acidosis
- •CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR<15ml/min per 1.73m2)
- •NYHA class IV or hemodynamic instability
- •Administration of any iodinated contrast medium 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
Berberine
Preoperative berberine 300 mg administration for at least 6 hours before interventional procedure, post-procedure berberine administration 100 mg at 24, 48 hours after procedure.
干预措施: Berberine (Drug)
结局指标
主要结局
Contrast-induced nephropathy
时间窗: 72 hours
An absolute increase in serum creatinine (SCr) \>=0.5mg/dL（\>=44.2μmmol/L）or a \>= 25% increase in SCr from baseline to 72 hours after the procedure
次要结局
- Major adverse renal events(30 days)
研究者
Shaoliang Chen, MD
Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital
Nanjing First Hospital, Nanjing Medical University