Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 368
- 试验地点
- 9
- 主要终点
- Incidence of contrast-induced nephropathy
研究概览
简要总结
The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.
详细描述
Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.
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 (Participant)
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
- •age>18 years, no upper limits
- •diabetes treated with insulin or oral hypoglycemic agents
- •serum creatinine >=1.1 and
- •resting estimated glomerular filtration rate <60ml/min/1.73 square meter
排除标准
- •serum creatinine >=8mg/dL
- •resting estimated GFR <15ml/min/1.73 square meter
- •end stage renal disease on hemodialysis
- •multiple myeloma
- •uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg)
- •acute myocardial infarction
- •emergent coronary angioplasty or angiography
- •recent use of contrast within 2 days
- •allergic reaction to contrast
- •pregnancy
- •allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine
研究组 & 干预措施
Sodium bicarbonate
sodium bicarbonate
干预措施: Sodium bicarbonate (Drug)
Saline
saline infusion
干预措施: saline (Drug)
结局指标
主要结局
Incidence of contrast-induced nephropathy
时间窗: 24 and 48 hours after angiography or intervention
次要结局
- all-cause mortality(30 days to 6 months after index angiography)
- stroke(30 days to 6 months after index angiography)
- Dialysis(30 days after index angiography)
- Myocardial infarction(30 days after index angiography)
- dialysis(30 days to 6 months after index angiography)
- myocardial infarction(30 days to 6 months after index angiography)