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Utility of NGAL to Diagnose AKI in Critically Ill Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03034876
Recruitment Status : Unknown
Verified January 2017 by Anwar ul Haq, Aga Khan University.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Anwar ul Haq, Aga Khan University

Brief Summary:
Acute Kidney Injury is common in critically ill children and is associated with high morbidity and mortality in pediatric intensive care unit. The serum creatinine is still a gold standard test for diagnosis of AKI, but it rises after 1 to 3 days of injury . However, Neutrophil Gelatinase-Associated Lipocalcin (NGAL) is an emerging biomarker in identifying AKI at an early stages, which may in future help us in promptly instituting reno-protective interventions like avoidance of nephrotoxic exposure and contrast agents, maintenance of euvolemia and perfusion pressure which will not only preventing kidney from further failing, decrease the use of very expensive and complicated renal supportive therapy like continuous renal replacement therapy (CRRT) as well as in decreasing morbidity and mortality related to AKI.

Condition or disease
Acute Kidney Injury in Critically Ill Children

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Kidney Injury Based on Neutrophil Gelatinase-Associated Lipocalcin (NGAL) in a Pediatric Intensive Care Unit of Tertiary Care Hospital Karachi, Pakistan
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Primary Outcome Measures :
  1. Incidence of Acute Kidney Injury [ Time Frame: within 24 hour ]
    serum will sent to plasma any time of day and test will run once a day

Biospecimen Retention:   Samples Without DNA
Plasma of participants will be analyzed for creatinine and Neutrophil Gelatinase-Associated Lipocalcin (NGAL

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All critically ill children admitted in pediatric intensive care unit and receiving inotrope

Inclusion Criteria:

All critically ill children who is recieving inotrope in pediatric intensive care unit -

Exclusion Criteria:

  • Pre-existing kidney disease
  • Chronic kidney disease
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Responsible Party: Anwar ul Haq, Associate Professor, Aga Khan University Identifier: NCT03034876    
Other Study ID Numbers: 4399-Ped-16
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anwar ul Haq, Aga Khan University:
"Acute Kidney Injury", diagnosis, children, shock
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases