Effect of Aminophylline on Contrast Induced Acute Kidney Injury in Patients With Acute Myocardial Infarction Treated With Primary Angioplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of Contrast-Induced Acute Kidney Injury
研究概览
简要总结
The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.
详细描述
Due to the clinical relevance of contrast acute kidney injury a large number of prophylactic procedures have been investigated. N-acetylcysteine and hydration with sodium bicarbonate are proved to be protective against contrast acute kidney injury. The adenosine-mediated afferent arteriolar vasoconstriction is a possible pathomechanism of renal impairment by contrast agent. It has been observed that aminophylline/theophylline, competitive adenosine antagonists, improves oxygen delivery to ischemic tissue, diminishes oxidative damage to renal tissue and may also scavenge free radicals.
The purpose of this study was to investigated whether the additional therapy with adenosine antagonist aminophylline reduces the incidence of contrast renal damage in high risk patients who have acute myocardial infarction.
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 (Investigator, 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
- •Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more than 1 mm in at least two contiguous leads of the electrocardiogram
排除标准
- •contrast medium administration within the previous 10 days,
- •end-stage renal failure requiring dialysis,
- •refusal to give informed consent
研究组 & 干预措施
Aminophylline
Additional Aminophylline therapy to hydration (sodium bicarbonate) and N-acetilcysteine
干预措施: Aminophylline (Drug)
Control group
Control group treated with hydration (sodium bicarbonate) and N-acetilcysteine
干预措施: Hydration plus N-acetylcisteine (Drug)
结局指标
主要结局
Incidence of Contrast-Induced Acute Kidney Injury
时间窗: 3 days
Contrast-Induced Acute Kidney Injury is defined as an increase in serum creatinine of \>=25% or 0.5 mg/dL over the baseline value within 3 days after the administration of the contrast medium
次要结局
- Adverse clinical events(1 month)
研究者
Mauro Maioli
Medical Doctor
Ospedale Misericordia e Dolce