MESNA Zur Prophylaxe Der Kontrastmittel-Induzierten Nephropathie
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
研究概览
简要总结
The purpose of this study is to determine wether Mesna could prevent contrast-induced nephropathy
详细描述
Contrast-induced nephropathy remains a common complication of radiographic precedures. Pretreatment with Mesna (Sodium 2-mercaptoethane sulfonate) in combination with sodium chloride is more protective than sodium chloride alone in animal models of acute renal failure.
The aim of this study is therefore to determine laboratory and clinical benefit of MESNA, as an adjunct to saline hydration, in patients with known renal impairment receiving contrast media.
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
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
- •stable chronic renal insufficiency
- •serum creatinine concentration > 1,5 mg/dl
排除标准
- •Dialyzed patients
- •patients with acute renal failure
- •received iodinated contrast media within 7 days before study entry
- •known allery to Mesna, pregnancy, and administration of dopamine, mannitol or N-acetylcysteine
结局指标
主要结局
Contrast-agent associated nephrotoxicity was defined as an increase in serum creatinine concentration >0.5 mg/dl (44 umol/l) of the baseline value 48 h after administration of the contrast media.
次要结局
- Need for dialysis after the administration of contrast media.