Clinical trial NCT00786708: Sensitivity and Specificity of NGAL in an Emergency Room Population
Official title: Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Azotemia
Renal Insufficiency, Chronic
Renal Failure, Acute
Hydronephrosis
Keywords: renal
kidney
lipocalin
urine
biomarker
Azotemia
Renal insufficiency, chronic
Renal failure, acute
Hydronephrosis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Abbott
name: Charite University, Berlin, Germany
name: Staten Island University Hospital
First posted: 2008-11-06
Enrollment: 2304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.
timeFrame: Assessed retrospectively after patient is discharged
Secondary outcomes:
measure: The correlation of urine NGAL and inpatient morbidity assessed by nephrology consultation and other factors such as dialysis initiation and intensive care unit stay.
timeFrame: Assessed retrospectively after patient is discharged
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Berlin
country: Germany
facility: Charite University Medical Center
Study officials:
affiliation: Columbia University
name: Thomas L. Nickolas, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Jonathan Barasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nickolas TL, Schmidt-Ott KM, Canetta P, Forster C, Singer E, Sise M, Elger A, Maarouf O, Sola-Del Valle DA, O'Rourke M, Sherman E, Lee P, Geara A, Imus P, Guddati A, Polland A, Rahman W, Elitok S, Malik N, Giglio J, El-Sayegh S, Devarajan P, Hebbar S, Saggi SJ, Hahn B, Kettritz R, Luft FC, Barasch J. Diagnostic and prognostic stratification in the emergency department using urinary biomarkers of nephron damage: a multicenter prospective cohort study. J Am Coll Cardiol. 2012 Jan 17;59(3):246-55. doi: 10.1016/j.jacc.2011.10.854.