Sensitivity and Specificity of NGAL in an Emergency Room Population

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT00786708

Collaborator

Abbott (Industry), Charite University, Berlin, Germany (Other), Staten Island University Hospital (Other)

2,304

Enrollment

Locations

Duration (Months)

768

Patients Per Site

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Azotemia Renal Insufficiency, Chronic Renal Failure, Acute Hydronephrosis

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 Design

Study Type:

Observational

Actual Enrollment :

2304 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
NGAL 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032
2	Staten Island University Hospital	Staten Island	New York	United States	10305
3	Charite University Medical Center	Berlin		Germany