Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease
NCT ID: NCT01845402
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2013-04-02
2015-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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congenital cardiac diseases
blood sample and urine sample.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent by one parent
* Health insurance
Exclusion Criteria
* Documented kidney or urinary malformation
* Failure to puncture a peripheral vein
10 Years
15 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Mirela Bojan, MD
Role: PRINCIPAL_INVESTIGATOR
Necker - Enfants Malades Hospital
Locations
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Necker - Enfants Malades Hospital
Paris, , France
Countries
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References
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Dimopoulos K, Diller GP, Koltsida E, Pijuan-Domenech A, Papadopoulou SA, Babu-Narayan SV, Salukhe TV, Piepoli MF, Poole-Wilson PA, Best N, Francis DP, Gatzoulis MA. Prevalence, predictors, and prognostic value of renal dysfunction in adults with congenital heart disease. Circulation. 2008 May 6;117(18):2320-8. doi: 10.1161/CIRCULATIONAHA.107.734921. Epub 2008 Apr 28.
Hogg RJ, Furth S, Lemley KV, Portman R, Schwartz GJ, Coresh J, Balk E, Lau J, Levin A, Kausz AT, Eknoyan G, Levey AS; National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics. 2003 Jun;111(6 Pt 1):1416-21. doi: 10.1542/peds.111.6.1416.
Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
Pedersen KR, Hjortdal VE, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Povlsen JV. Clinical outcome in children with acute renal failure treated with peritoneal dialysis after surgery for congenital heart disease. Kidney Int Suppl. 2008 Apr;(108):S81-6. doi: 10.1038/sj.ki.5002607.
Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9. doi: 10.1038/sj.ki.5000032.
Other Identifiers
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P091125
Identifier Type: -
Identifier Source: org_study_id