Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed
研究概览
简要总结
Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.
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
- None
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
- •> 18 years old
- •cancer diagnosis
- •GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic
- •CT with contrast
排除标准
- •dialysis needed
- •uncontrolled hypertension
- •changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
- •recent exposure to radiographic contrast agents (within previous two days of the study)
- •administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
研究组 & 干预措施
sodium bicarbonate
Solution 154 mEq/L of sodium bicarbonate
干预措施: sodium bicarbonate (Drug)
Sodium chloride
Solution of 154 mEq/L of NaCl
干预措施: NaCl (Drug)
结局指标
主要结局
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed
时间窗: 2 days
次要结局
- change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level(2 days)