NGAL, an Early Predictive Marker of Acute Kidney Injury After Cardiac Surgery in Neonates and Infants
Condition: Peritoneal Lesion
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      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: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        heterogeneous populations of children undergoing cardiac surgery
      
Biospecimen description: 
      Blood and urine samples are collected during the early postoperative period, stored, than
      NGAL concentrations are measures on the ARCHITECT platform.
    
Keywords: Postoperative Complications; Acute Kidney Failure; Peritoneal Dialysis; NGAL