An observational study in Azotemia, Renal Insufficiency, Chronic and Renal Failure, Acute, sponsored by Columbia University. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-10.
Sponsored by Columbia University · Observational
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.
2 studies on the registry are indexed under Azotemia; none are open to participants now.
Browse Azotemia studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.
Inclusion Criteria:
A. Must be greater than or equal to 18 years of age
B. Must satisfy the following age and sex stratified serum creatinine levels:
C. All pts greater than or equal to 18 years of age without kidney failure defined by B
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 correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.
Time frame: Assessed retrospectively after patient is discharged
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
The record gives a start of Dec 2006, a primary completion of Dec 2009 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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