Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Prevention of contrast induced acute kidney injury
研究概览
简要总结
A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)
详细描述
Eligible patients (patients with glomerular filtration rate < 60 ml/min or high riks patients based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1 exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post radiocontrast exposure) or placebo and hydration.
Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy
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
- Double (Participant, Investigator)
盲法说明
Double blind clinical trial
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older who are scheduled to coronary intervention
- •Patients with Mehran score > 5 or modified Mehran score >2 even glomerular filtration rate > 60 ml/min (high risk patients)
- •Glomerular Filtration Rate < 60 ml/min
- •All the patients provided written informed consent for the procedures and the test drug
排除标准
- •Patients with shorter hospital stay (<48 hours)
- •Patients under treatment with allopurinol of febuxostat
- •Patients on renal replacement therapy
- •Known allergy to allopurinol or febuxostat
研究组 & 干预措施
Allopurinol group
The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
干预措施: Allopurinol (Drug)
Placebo group
The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
干预措施: Placebo (Drug)
Febuxostat group
The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
干预措施: Febuxostat (Drug)
结局指标
主要结局
Prevention of contrast induced acute kidney injury
时间窗: 48 hours
Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
次要结局
- Renal replacement therapy requirement(7 days)
- Length of hospitalization(3 days to 90 days)
研究者
Magdalena Madero
Nephrology Department
Instituto Nacional de Cardiologia Ignacio Chavez