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Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population
Hypothesis: In patients that present to an urban emergency room, a single urine neutrophil gelatinase-associated lipocalin (NGAL) measurement can classify their kidney disease as stable chronic kidney disease, acute tubular necrosis, urinary outlet obstruction or pre-renal azotemia.
The purpose of this study is to determine whether urinary NGAL levels are able to distinguish the classical categories of renal disease. Previous studies have strongly suggested that this protein marks those with fulminant renal dysfunction with greater sensitivity and time resolution than currently used markers. Studies to date have been in highly selected populations: children and adults following cardiac surgery, infants with cardiovascular anomalies, and patients with known chronic kidney disease. Demonstration of similarly robust sensitivity and specificity in a broad Emergency Room population would strengthen the conception of NGAL as a marker of early or advancing kidney dysfunction. Most importantly, if NGAL can distinguish between types of renal disease at presentation in the ER, it might have important implications regarding ER management of these common presentations. For example, it could reduce diagnostic ambiguity and lag time from hours or days to seconds.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Columbia University Medical Center
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Charite University Medical Center
Berlin, Germany
Start Date
December 1, 2006
Primary Completion Date
December 1, 2009
Completion Date
July 1, 2013
Last Updated
February 10, 2014
2,304
ACTUAL participants
Lead Sponsor
Columbia University
Collaborators
NCT06314503
NCT06863194
Data Source & Attribution
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