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

Completed

• Conditions: Peritoneal Lesion

• Registration Number: NCT01219998
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NGAL kinetics	from 2 hours to 48 hours	describe the kinetics of urinary NGAL in neonates after open heart surgery

Secondary Outcome Measures

Name	Time	Method
NGAL Biomarkers	from 2 hours to 48 hours	Setup of a sample repository, which will allow to study future biomarkers of AKI
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

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France