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.

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Key information

Conditions

Azotemia Acute Kidney Injury Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure, Acute Renal Insufficiency Renal Insufficiency, Chronic Uremia Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite University Medical Center, Berlin, Germany

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
men older than 50 with serum creatinine greater than 1.0mg/dl
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

Treatment and study plan

Primary outcomes

The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.

Time frame: Assessed retrospectively after patient is discharged

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Abbott
Charite University, Berlin, Germany
Staten Island University Hospital

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2013
First posted: Nov 6, 2008
Registry last updated: Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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