Sensitivity and Specificity of NGAL in an Emergency Room Population

Completed

• Conditions: Azotemia; Hydronephrosis; Renal Insufficiency, Chronic; Renal Failure, Acute

• Registration Number: NCT00786708
• Lead Sponsor: Columbia University

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 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2009-12
• Study Completion: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-07
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2304

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:

1. men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
2. women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
3. men older than 50 with serum creatinine greater than 1.0mg/dl
4. women older than 50 with serum creatinine greater than 0.8mg/dl

C. All pts greater than or equal to 18 years of age without kidney failure defined by B

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.	Assessed retrospectively after patient is discharged

Secondary Outcome Measures

Name	Time	Method
The correlation of urine NGAL and inpatient morbidity assessed by nephrology consultation and other factors such as dialysis initiation and intensive care unit stay.	Assessed retrospectively after patient is discharged

Trial Locations

Locations (3)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Charite University Medical Center; 🇩🇪 Berlin, Germany

Staten Island University Hospital; 🇺🇸 Staten Island, New York, United States