Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease

NCT01845402 | Completed

• 1 other identifier: P091125
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Failure; Congenital Heart Defects

Keywords

Kidney Failure, Chronic; Adolescent; Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• Chronic kidney disease

  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.

  at Day 0

Secondary Outcomes (1)

• Peri-operative risk factors

  at day 0

Study Arms (1)

congenital cardiac diseases

blood sample and urine sample.

Biological: blood and urine samples

Interventions

blood and urine samples BIOLOGICAL

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.

congenital cardiac diseases

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients 10 to 15 years old with congenital cardiac diseases

You may qualify if:

• 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

You may not qualify if:

• Documented chronic kidney disease of non cardiac origin
• Documented kidney or urinary malformation
• Failure to puncture a peripheral vein

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker - Enfants Malades Hospital

Paris, 75015, France

Location

Related Publications (6)

• 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.

  PMID: 18443238 BACKGROUND

• 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.

  PMID: 12777562 BACKGROUND

• 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.

  PMID: 15882252 BACKGROUND

• 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.

  PMID: 18379554 BACKGROUND

• 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.

  PMID: 16374442 BACKGROUND

• Lorut C, Lefebvre A, Planquette B, Quinquis L, Clavier H, Santelmo N, Hanna HA, Bellenot F, Regnard JF, Riquet M, Magdeleinat P, Meyer G, Roche N, Huchon G, Coste J, Rabbat A. Early postoperative prophylactic noninvasive ventilation after major lung resection in COPD patients: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):220-227. doi: 10.1007/s00134-013-3150-2. Epub 2013 Nov 29.

  PMID: 24292873 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

sample of blood and urine

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Defects, Congenital

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mirela Bojan, MD

  Necker - Enfants Malades Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: May 3, 2013
• Study Start: April 2, 2013
• Primary Completion: June 19, 2015
• Study Completion: June 20, 2015
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)