Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.
详细描述
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 aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary 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
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Patient that underwent coronary angiography
- •CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
- •Alprostadil naive, or not on Alprostadil treatment for at least 14 days
- •Withdrawal metformin or aminophylline for 48h before angiography
排除标准
- •serum Cr. More than 3 mg/dl
- •electrolyte and acid-base imbalance
- •pulmonary edema
- •allergy to Alprostadil
研究组 & 干预措施
Alprostadil, Control
Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography
干预措施: Alprostadil ﹠control (Drug)
结局指标
主要结局
Primary Outcome
时间窗: 72 h
An absolute increase in SCr \>=0.5mg/dL（\>=44.2μmmol/L）or a \>= 25% increase in SCr from baseline to 72h after the procedure
次要结局
- Secondary Outcome(30 d)
研究者
Ya-Wei Xu
MD FACC
Shanghai 10th People's Hospital