Peritoneal Lesion Clinical Trial
— NGALOfficial title:
Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants
| Verified date | May 2013 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Observational |
Urinary NGAL has been shown to be an early marker of acute kidney injury (AKI) following
paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early
increase of urinary NGAL following cardiopulmonary bypass was predictive of AKI. Several
studies included heterogeneous populations of children undergoing cardiac surgery, but NGAL
has not been studied in neonates after open heart surgery, neither has been identified the
threshold for accurate prediction of severe AKI requiring renal replacement therapy.
The aim of this observational cohort study is to describe postoperative kinetics of urinary
NGAL in neonates and to identify the threshold for accurate prediction of severe AKI
requiring renal replacement therapy in neonates and infants undergoing cardiac surgery
| Status | Completed |
| Enrollment | 205 |
| Est. completion date | November 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 12 Months |
| Eligibility |
Inclusion criteria : - term neonates and infants undergoing heart surgery with cardiopulmonary bypass - parents received written information Exclusion criteria : - preoperative documented kidney injury - parents not informed, opposed |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Necker Hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12. — View Citation
Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21. Review. — View Citation
Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NGAL kinetics | describe the kinetics of urinary NGAL in neonates after open heart surgery | from 2 hours to 48 hours | No |
| Secondary | Ngal Threshold | identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy | from 2 hours to 48 hours | No |
| Secondary | NGAL Algorithm | Development of an algorithm combining early clinical and laboratory criteria (including urinary NGAL) for prevention of renal failure and/or its worsening, and for early initiation of RRT in neonates and infants after cardiac surgery | from 2 hours to 48 hours | No |
| Secondary | NGAL Biomarkers | Setup of a sample repository, which will allow to study future biomarkers of AKI | from 2 hours to 48 hours | No |