Evaluation of the Incidence of Renal Stress by Measuring the NephroCheck Test After Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 主要终点
- Test fresh urine samples by NephroCheck
研究概览
简要总结
Blood and urine samples of over 200 pediatric subjects (over 28 days to 3 years) undergoing complex cardiac surgery with cardiopulmonary bypass (CPB) will be collected at several time points to measure corresponding biomarkers such as serum creatinine, serum urea concentration, or NephroCheck test ([TIMP-2]*[IGFBP7) to evaluate the diagnostic performance of AKI by NephroCheck test .
详细描述
At least 200 subjects having undergone pediatric cardiac surgery with cardiopulmonary bypass (CPB). Enrollment will continue with a maximum of 350 subjects until 30 cases of AKI (stage 2 and 3) are reached.
Blood and urines samples will be collected at several time points to measure biomarkers and set up a biobank.
The samples used within the scope of this protocol will be fresh urine samples (1 to 2 ml) and blood samples.
Urine samples for [TIMP-2]*[IGFBP7] measurements will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule:
- baseline before initiation of cardiopulmonary bypass (CPB, 0h).
-
- 2h, 4h, 6h, 8h, 12h, 24h, 48h after initiation of CPB
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
- 28 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign the consent form
- •Clinical diagnosis of complex congenital heart surgery (Risk Adjusted classification for Congenital Heart Surgery [RACHS] score >=2)
- •Must undergo elective cardiac surgery with CPB
排除标准
- •Clinical diagnosis of severe pre-existing renal insufficiency (SCr >2 times age-adjusted normal range)
- •Significant abnormalities of the kidneys or genitourinary tract
结局指标
主要结局
Test fresh urine samples by NephroCheck
时间窗: up to one year
Urine samples for \[TIMP-2\]\*\[IGFBP7\] measurements will be taken from each subject included in the study during the first 48 hours following cardiopulmonary bypass initiation according to the following schedule: * baseline before initiation of cardiopulmonary bypass (CPB, 0h). * - 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours after initiation of CPB
次要结局
- Test serum creatinine and urea concentration to report AKI according KDIGO guideline(up to one year)