Chronic Kidney Failure Clinical Trial
Official title:
The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood
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.
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.
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