Sensitivity and Specificity of 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.
Renal Insufficiency, Chronic
Renal Failure, Acute
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population|
- The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury. [ Time Frame: Assessed retrospectively after patient is discharged ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||December 2006|
|Study Completion Date:||July 2013|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Urine that would otherwise be discarded will be obtained from a convenience sample of patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786708
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10305|
|Charite University Medical Center|
|Principal Investigator:||Thomas L. Nickolas, MD, MS||Columbia University|
|Principal Investigator:||Jonathan Barasch, MD, PhD||Columbia University|