Peritoneal Lesion
Conditions
Keywords
Postoperative Complications, Acute Kidney Failure, Peritoneal Dialysis, NGAL
Brief 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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NGAL kinetics | from 2 hours to 48 hours | describe the kinetics of urinary NGAL in neonates after open heart surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ngal Threshold | from 2 hours to 48 hours | identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy |
| NGAL Algorithm | from 2 hours to 48 hours | 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 |
| NGAL Biomarkers | from 2 hours to 48 hours | Setup of a sample repository, which will allow to study future biomarkers of AKI |
Countries
France
Outcome results
None listed