Evaluation of eGFR, Determined by Cystatin C and Creatinine, and mGFR, Measured by Iohexol Clearance, in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Correlation between eGFR and mGFR
研究概览
简要总结
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery
详细描述
This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 45 years old
- •At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
- •Reduced renal function
- •Diabetes with ongoing insulin treatment
- •Albuminuria
- •Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
排除标准
- •Emergent surgeries, including aortic dissection, and major congenital heart defects
- •Past cardiac surgery off CPB
- •Have a known allergy to iohexol
结局指标
主要结局
Correlation between eGFR and mGFR
时间窗: at 90 days post cardiac surgery
The primary measure will be the comparison of the P(30) and P(10) between eGFR based on serum cystatin C (eGFRcys) and eGFR based on serum creatinine (eGFRcreat). P(30) and P(10) are defined as the percentage of subjects whose eGFR is within 30% (10%) of the iohexol-based mGFR.
次要结局
未报告次要终点