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Sensitivity and Specificity of NGAL in an Emergency Room Population

This study has been completed.
Sponsor:
Collaborators:
Abbott
Charite University, Berlin, Germany
Staten Island University Hospital
Information provided by (Responsible Party):
Thomas Nickolas, Columbia University
ClinicalTrials.gov Identifier:
NCT00786708
First received: November 5, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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
Azotemia
Renal Insufficiency, Chronic
Renal Failure, Acute
Hydronephrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury. [ Time Frame: Assessed retrospectively after patient is discharged ] [ Designated as safety issue: No ]

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. [ Time Frame: Assessed retrospectively after patient is discharged ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Urine


Enrollment: 2304
Study Start Date: December 2006
Study Completion Date: July 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786708

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Staten Island University Hospital
Staten Island, New York, United States, 10305
Germany
Charite University Medical Center
Berlin, Germany
Sponsors and Collaborators
Columbia University
Abbott
Charite University, Berlin, Germany
Staten Island University Hospital
Investigators
Principal Investigator: Thomas L. Nickolas, MD, MS Columbia University
Principal Investigator: Jonathan Barasch, MD, PhD Columbia University
  More Information

Publications:
Responsible Party: Thomas Nickolas, Assistant Professor of Medicine, Department of Medicine, Nephrology, Columbia University
ClinicalTrials.gov Identifier: NCT00786708     History of Changes
Other Study ID Numbers: AAAC1584
Study First Received: November 5, 2008
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
Germany: Ethics Commission

Keywords provided by Columbia University:
renal
kidney
lipocalin
urine
biomarker
Azotemia
Renal insufficiency, chronic
Renal failure, acute
Hydronephrosis

Additional relevant MeSH terms:
Acute Kidney Injury
Azotemia
Hydronephrosis
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Pathologic Processes
Uremia
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014