Chronic Kidney FailurePRECARDIONCT01845402
Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease
An observational study of Chronic Kidney Failure and Congenital Heart Defects, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Chronic Kidney Failure, Congenital Heart Defects
- What is being tested?
- blood and urine samples
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2013to 20 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients 10 to 15 years old with congenital cardiac diseases
Who may be able to join
- 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
Who cannot join
- Documented chronic kidney disease of non cardiac origin
- Documented kidney or urinary malformation
- Failure to puncture a peripheral vein
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Failure, Congenital Heart Defects
- Being tested
- blood and urine samples
- Keywords
- Kidney Failure, Chronic, Adolescent, Heart Defects, Congenital
- Medical subject headings
- Kidney Failure, Chronic, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urine samplesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| congenital cardiac diseases | blood sample and urine sample. Receives: Biological: blood and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Day 0
Secondary outcomes (1)
Peri-operative risk factors
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.
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start2 Apr 2013
- Primary completion19 Jun 2015
- Study completion20 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Mirela Bojan, MD, Principal investigator, Necker - Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845402
- Sponsor's protocol ID
- P091125
- Acronym
- PRECARDIO
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2012
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18443238Hogg 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.
PubMed 12777562Levey 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.
PubMed 15882252Pedersen 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.
PubMed 18379554Askenazi 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.
PubMed 16374442Lorut 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.
PubMed 24292873
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood
- ClinicalTrials.gov ID
- NCT01845402
- Acronym / sponsor ID
- PRECARDIO / P091125
- Conditions
- Chronic Kidney Failure, Congenital Heart Defects
- Keywords
- Kidney Failure, Chronic, Adolescent, Heart Defects, Congenital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Apr 2013 (actual)
- Primary completion
- 19 Jun 2015 (actual)
- Study completion
- 20 Jun 2015 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital cardiac diseases | – | Biological: blood and urine samplesblood sample and urine sample. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients 10 to 15 years old with congenital cardiac diseases
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Documented chronic kidney disease of non cardiac origin
- Documented kidney or urinary malformation
- Failure to puncture a peripheral vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urine samplesA 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. | Biological | congenital cardiac diseases |
Primary outcome
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.
1 secondary outcome
Peri-operative risk factors
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 18443238Dimopoulos 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.
- Background: PubMed 12777562Hogg 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.
- Background: PubMed 15882252Levey 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.
- Background: PubMed 18379554Pedersen 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.
- Background: PubMed 16374442Askenazi 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.
- Results publication: PubMed 24292873Lorut 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirela Bojan, MD principal investigator
Necker - Enfants Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Failure and Congenital Heart Defects, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic kidney disease (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01845402, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.