NGAL, an Early Predictive Marker of Acute Kidney Injury After Cardiac Surgery in Neonates and Infants

Study Overview
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Brief Summary
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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

Detailed Description
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Urinary NGAL has been shown to be an early marker of AKI following paediatric cardiac surgery (2 hours off pump). Previous studies showed that an early increase of urinary NGAL following cardiopulmonary bypass was an excellent predictor for a later >50% increase in serum creatinine concentration in children undergoing cardiac surgery. Increased urinary concentrations of NGAL were found following open heart surgery. When defining AKI as an >50% increase of serum creatinine from baseline, the increase of urinary NGAL concentration two hours off pump appeared to be an excellent predictor of AKI. Several studies included heterogeneous populations of patients aged one month to 21 years undergoing cardiac surgery. Besides, NGAL concentrations have 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 (RRT). If such a threshold was identified, urinary NGAL could be provided for intervention. 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 RRT in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass. The study is entirely observational, the decision to initiate RRT continues to be based on clinical evidence of fluid overload, low cardiac output and oliguria. Urine samples are collected during the early postoperative period, stored, than NGAL concentrations are measures on the ARCHITECT platform.

Official Title
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Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants

Conditions
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Peritoneal Lesion

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NGAL Kinetics in neonates<br>to describe postoperative kinetics of urinary NGAL in neonates and to identify the threshold for accurate prediction of severe AKI requiring RRT in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NGAL kinetics | describe the kinetics of urinary NGAL in neonates after open heart surgery | from 2 hours to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ngal Threshold | identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy | from 2 hours to 48 hours | 
| 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 | 
| NGAL Biomarkers | Setup of a sample repository, which will allow to study future biomarkers of AKI | from 2 hours to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Complications, Acute Kidney Failure, Peritoneal Dialysis, NGAL