NCT01218828已完成3 期
Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Contrast induced nephropathy
研究概览
简要总结
Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.
详细描述
The study population will be recruited from subjects undergoing cardiac catheterization.
Subjects will be randomized to one of two hydration protocols:
- normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure.
- normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) < 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) > 18 mmHg, 1.5 mL/kg during and four hours post procedure.
Renal function assessment will be made using standard laboratory measures post procedure.
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
- Single (Participant)
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
- •estimated GFR less than or equal to 60 mL/min/1.73 m^2
- •age greater than 18 years
- •at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years.
排除标准
- •patients unable to give consent
- •undergoing emergency cardiac catheterization
- •on renal replacement therapy
- •exposure to contrast media within the prior two days
- •pulmonary edema or active congestive heart failure
- •kidney transplant status
- •severe valvular abnormalities
- •change in serum creatinine greater than 15% over the prior two days
结局指标
主要结局
Contrast induced nephropathy
时间窗: Within four days of contrast exposure
次要结局
- Renal replacement therapy, myocardial infarction, all-cause mortality(30 days and long-term)
研究者
研究点 (2)
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