Sensitivity and Specificity of NGAL in an Emergency Room Population

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786708
• Other study ID #: AAAC1584
• Status: Completed
• Phase: N/A
• First received: November 5, 2008
• Last updated: February 7, 2014
• Start date: December 2006
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentGermany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2304
• Est. completion date: July 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Azotemia
• Hydronephrosis
• Renal Failure, Acute
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	Charite University Medical Center	Berlin
United States	Columbia University Medical Center	New York	New York
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Abbott, Charite University, Berlin, Germany, Staten Island University Hospital

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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, Sag — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.		Assessed retrospectively after patient is discharged	No
Secondary	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	No