Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
试验速览
- 阶段
- 4 期
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
研究概览
简要总结
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
详细描述
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
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 (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
- •minimum 18 years old
- •chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
- •hemodynamically stable
排除标准
- •Acute renal failure or in recuperation of acute renal failure
- •urgent coronary angiogram
- •moderate to severe valvulopathy or presence of a valvular prosthesis
- •diagnostic of multiple myeloma
- •dialysis before test
- •having had a test with contrast product in the 2 weeks preceding
- •receiving a nephrotoxic in the last month.
研究组 & 干预措施
A: Hydratation according LVEDP + NaHCO3
Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.
干预措施: Hydratation according LVEDP + NaHCO3 (Other)
B: Standard hydratation
hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
干预措施: normal saline (Other)
C: Hydratation with sodium bicarbonate
hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
干预措施: Sodium bicarbonate (Other)
结局指标
主要结局
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
时间窗: 48 hours
次要结局
- changes in glomerular filtration in the 3 groups (measured with MDRD formula)(48 hours)
- clinical events during the procedure or after (ex. pulmonary edema)(during hospitalisation)
- Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours(48 hours)
研究者
Michel Nguyen
Doctor
Université de Sherbrooke