NCT01840241已完成不适用
Effect of Sodium Bicarbonate on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass (OPCAB)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- compare the incidence of acute kidney injury
研究概览
简要总结
In this single-site, randomized, controlled and double-blind clinical trial, the investigators evaluate the effect of sodium bicarbonate on prevention of acute kidney injury in high risk patients undergoing off pump coronary bypass surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years
- •scheduled for elective coronary artery bypass grafting.
- •preoperative estimated glomerular filtration rate (eGFR) : 30 ~ 89 %
- •LVEF < 35%
- •NYHA class III or IV
- •age > 70
- •reoperation
排除标准
- •acute renal impairment
- •patients who receive dialysis
- •patients who receive steroid ( > 10mg/day prednisolon or equivalent)
- •hemo-alkalosis
- •hypernatremia
- •pulmonary edema
- •Hemoglobin < 10 mg/dL
研究组 & 干预措施
BIVON group
Experimental
干预措施: sodium bicarbonate (Drug)
Placebo group
Placebo Comparator
normal saline infusion
干预措施: normal saline (Drug)
结局指标
主要结局
compare the incidence of acute kidney injury
时间窗: Change of Indexes of renal function including SCr, cystatin C, creatinine clearance from 24 hrs before operation to postoperative day (POD) 5.
The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation).
次要结局
未报告次要终点
研究者
研究点 (1)
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