Clinical Trial: Sensitivity and Specificity of NGAL in an Emergency Room Population

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Columbia University

Current Primary Outcome: The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury. [ Time Frame: Assessed retrospectively after patient is discharged ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The correlation of urine NGAL and inpatient morbidity assessed by nephrology consultation and other factors such as dialysis initiation and intensive care unit stay. [ Time Frame: Assessed retrospectively after patient is discharged ]

Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: November 5, 2008
Date Started: December 2006
Date Completion:
Last Updated: February 7, 2014
Last Verified: February 2014