The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
研究概览
简要总结
The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis
排除标准
- •end stage renal disease (serum creatinine concentration > 300 μmol/L)
- •on dialysis
- •chronic moderate to high dose corticosteroid therapy (> 10 mg/day prednisolon or equivalent)
- •preoperative severe hypernatremia (Na+ > 150 mmol/L), alkalemia (PH > 7.50), or pulmonary edema
- •neurocognitive dysfunction
研究组 & 干预措施
Sodium bicarbonate group
Sodium bicarbonate group
干预措施: sodium bicarbonate (Drug)
Saline group
Saline group
干预措施: Saline (Drug)
结局指标
主要结局
Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
时间窗: postoperative 48 hours
We would investigate if the peak creatinine level during the postoperative 48h would differ by more than 0.3 mg/dL between two groups. The primary outcome was decided based on the AKIN criteria which defines acute kidney injury if serum creatinine increases more than 0.3 mg/dL during the postoperative 48 h. ; increase in serum creatinine of 0.3 mg/dL or \>50 percent developing over \<48 hours
次要结局
未报告次要终点