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

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


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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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



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.


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219998


Locations
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France
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mirela Bojan, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases