Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-acetylcysteine in Patients Undergoing Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The incidence of contrast induced nephropathy, defined as 25% or more increase in serum creatinine within 2 days of contrast administration, will be assessed.
研究概览
简要总结
The objective of this study is to assess the efficacy of sodium bicarbonate compared with sodium chloride and oral N-acetylcysteine (NAC ) pretreatment for prevention of contrast nephropathy in patients with advanced renal disease undergoing cardiac catheterisation.
详细描述
PROTOCOL
Prevention of Contrast Nephropathy by Sodium Bicarbonate Versus Sodium Chloride and N-Acetylcysteine
Nephrology and Cardiology Services, Shaare Zedek Medical Center, Jerusalem
- Background and rationale
The development of acute renal failure following cardiac catheterization has been recognized since the 1970's. The syndrome of acute renal failure following cardiac catheterization is presently felt to be due either to atheroembolic disease or what is now referred to as contrast induced nephropathy. Since the clinical course of each is different, it is now usually not difficult to diagnose acute contrast induced nephropathy.
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
- •Eligible patients include individuals aged 18 year or older with GFR 15-60ml/min calculated by MDRD formula, who were scheduled to undergo cardiac catheterization. During the randomized study, consecutive eligible patients scheduled for exposure to the nonionic radiographic contrast agent iopamidol (796 mOsm/kg H2O, 755 mg of iopamidol per milliliter, and 370 mg iodine per milliliter) will be considered for enrollment.
排除标准
- •i. Serum creatinine levels more than 8mg/dl or GFR less than 15ml/min
- •ii. Change in serum creatinine levels of ³0.5mg/dl during the previous 24 hours.
- •iii. Preexisting dialysis
- •iv. Multiple myeloma.
- •v. Pulmonary edema.
- •vi. Uncontrolled hypertension (treated systolic blood pressure more than 160 mmHg, or diastolic blood pressure more than 100mmHg.)
- •vii. Emergency catheterization.
- •viii. Recent exposure to radiographic contrast (within two days of the study).
- •ix. Allergy to radiocontrast.
- •x. Pregnancy.
- •xi. Administration of dopamine, mannitol or NAC before the study.
结局指标
主要结局
The incidence of contrast induced nephropathy, defined as 25% or more increase in serum creatinine within 2 days of contrast administration, will be assessed.
次要结局
未报告次要终点