Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease (PRECARDIO)
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|ClinicalTrials.gov Identifier: NCT01845402|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment|
|Chronic Kidney Failure Congenital Heart Defects||Biological: blood and urine samples|
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.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood|
|Actual Study Start Date :||April 2, 2013|
|Actual Primary Completion Date :||June 19, 2015|
|Actual Study Completion Date :||June 20, 2015|
congenital cardiac diseases
blood sample and urine sample.
Biological: blood and urine samples
A blood sample and urine sample will be collected for purpose of the study. CKD (Chronic kidney injury) will be diagnosed according to the KDIGO criteria in children.
- Chronic kidney disease [ Time Frame: 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.
- Peri-operative risk factors [ Time Frame: at day 0 ]The secondary aim is the identification of peri-operative risk factors of chronic kidney disease in this population, by retrospective chart-review and regression analysis.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845402
|Necker - Enfants Malades Hospital|
|Paris, France, 75015|
|Principal Investigator:||Mirela Bojan, MD||Necker - Enfants Malades Hospital|