NCT00786708

Sensitivity and Specificity of NGAL in an Emergency Room Population

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,304 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Azotemia
• Renal Insufficiency, Chronic
• Renal Failure, Acute
• Hydronephrosis

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-12-01
• Completion: 2013-07-01
• First posted: 2008-11-06
• Last updated: 2014-02-10

Locations

3 sites across 2 countries: United States, Germany