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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00786708

Enrollment

2304

Registered

2008-11-06

Start date

2006-12-31

Completion date

2013-07-31

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

renal, kidney, lipocalin, urine, biomarker, Azotemia, Renal insufficiency, chronic, Renal failure, acute, Hydronephrosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany, United States

Outcome results