The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Chronic kidney disease
研究概览
简要总结
The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.
详细描述
Background. Acute kidney injury is a common complication of cardiac surgery in children. The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known. The only study published to date is that of Dimopoulos et al., who has estimated the prevalence of CKD in young adults with congenital cardiac diseases at 40% and the prevalence of stage 2 CKD at 6% (Dimopoulos, Circulation 2008). The study by Dimopoulos et al. also showed that CKD was a risk factor of death in this population. Objectives. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could be predictive of CKD.
Methodology. The study has been approved by the Ethical Committee of our institution, and is founded by the Departement de la Recherche Clinique et du Developpement, AP-HP, Paris This is a prospective observational cross-sectional study which will enroll patients 10 to 15 years with congenital cardiac diseases, who have undergone surgical repair during childhood. Only patients who have undergone surgery and follow-up at our institution will be enrolled, to insure complete data. The patients will receive complete information about the study by mail that will be send home prior to the appointment for the cardiologic follow-up. After parental and patient consent, a sample of blood and urine will be collected for purpose of the study. CKD will be diagnosed according to the KDIGO criteria in children (Hogg, Pediatrics 2003). In case of CKD, patients will be informed and given an appointment for nephrological support and follow-up at our institution. The prevalence and stage of CKD will be calculated after completion of inclusions. The risk factors of CKD will be identified retrospectively by chart review and regression analysis.
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
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 10 to15 years, having undergone surgery for congenital heart disease during childhood, and cardiologic follow-up at Necker-Enfants Malades Hospital
- •Written informed consent by one parent
- •Health insurance
排除标准
- •Documented chronic kidney disease of non cardiac origin
- •Documented kidney or urinary malformation
- •Failure to puncture a peripheral vein
研究组 & 干预措施
congenital cardiac diseases
blood sample and urine sample.
干预措施: blood and urine samples (Biological)
结局指标
主要结局
Chronic kidney disease
时间窗: at Day 0
The primary measure is the prevalence of chronic kidney disease in teenagers and pre-teenagers with congenital heart disease operated during childhood. For screening purposes, a blood and a urine sample will be collected the day of consultation for the cardiologic follow-up.
次要结局
- Peri-operative risk factors(at day 0)