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

• ClinicalTrials.gov Identifier: NCT01219998
• Recruitment Status: Completed
• First Posted: October 13, 2010
• Last Update Posted: May 23, 2013
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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

Condition or disease
Peritoneal Lesion

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 Design

• Study Type: Observational
• Actual Enrollment: 205 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Predictive Ability of Urinary NGAL as an Early Marker of Acute Kidney Injury Following Cardiac Surgery in Neonates and Infants
• Study Start Date: August 2010
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: November 2012

Groups and Cohorts

Group/Cohort
NGAL Kinetics in neonates; 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

Outcome Measures

Primary Outcome Measures :

1. NGAL kinetics [ Time Frame: from 2 hours to 48 hours ]
   describe the kinetics of urinary NGAL in neonates after open heart surgery

Secondary Outcome Measures :

1. Ngal Threshold [ Time Frame: from 2 hours to 48 hours ]
   identify the threshold for accurate prediction of severe AKI requiring renal replacement therapy
2. NGAL Algorithm [ Time Frame: 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
3. NGAL Biomarkers [ Time Frame: from 2 hours to 48 hours ]
   Setup of a sample repository, which will allow to study future biomarkers of AKI

Biospecimen Retention:   Samples Without DNA

Blood and urine samples are collected during the early postoperative period, stored, than NGAL concentrations are measures on the ARCHITECT platform.

Eligibility Criteria

• Ages Eligible for Study: up to 12 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

heterogeneous populations of children undergoing cardiac surgery

Criteria

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

Contacts and Locations

Locations

France

Necker Hospital

Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Mirela Bojan, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bojan M, Basto Duarte MC, Lopez V, Tourneur L, Vicca S, Froissart M. Low perfusion pressure is associated with renal tubular injury in infants undergoing cardiac surgery with cardiopulmonary bypass: A secondary analysis of an observational study. Eur J Anaesthesiol. 2018 Aug;35(8):581-587. doi: 10.1097/EJA.0000000000000782.

Bojan M, Basto Duarte MC, Ermak N, Lopez-Lopez V, Mogenet A, Froissart M. Structural equation modelling exploration of the key pathophysiological processes involved in cardiac surgery-related acute kidney injury in infants. Crit Care. 2016 Jun 5;20(1):171. doi: 10.1186/s13054-016-1350-1.

Bojan M, Vicca S, Lopez-Lopez V, Mogenet A, Pouard P, Falissard B, Journois D. Predictive performance of urine neutrophil gelatinase-associated lipocalin for dialysis requirement and death following cardiac surgery in neonates and infants. Clin J Am Soc Nephrol. 2014 Feb;9(2):285-94. doi: 10.2215/CJN.04730513. Epub 2013 Nov 21.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01219998
• Other Study ID Numbers: CRC08103; K080602 ( Other Identifier: AP-HP )
• First Posted: October 13, 2010
• Last Update Posted: May 23, 2013
• Last Verified: May 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Postoperative Complications; Acute Kidney Failure; Peritoneal Dialysis; NGAL

Additional relevant MeSH terms:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases