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Sensitivity and Specificity of NGAL in an Emergency Room Population
This study is currently recruiting participants.
Verified by Columbia University, November 2008
First Received: November 5, 2008   No Changes Posted
Sponsors and Collaborators: Columbia University
Abbott
Charite University, Berlin, Germany
Staten Island University Hospital
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00786708
  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

MedlinePlus related topics: Kidney Failure Urine and Urination
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population

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

Biospecimen Description:

Urine


Estimated Enrollment: 2250
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786708

Contacts
Contact: Thomas L Nickolas, MD, MS tln2001@columbia.edu
Contact: Jonathan Barasch, MD, PhD jmb4@columbia.edu

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

No publications provided

Responsible Party: Columbia University Medical Center ( Thomas L. Nickolas, MD and Jonathan Barasch, MD )
Study ID Numbers: AAAC1584
Study First Received: November 5, 2008
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00786708     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government;   Germany: Ethics Commission

Keywords provided by Columbia University:
renal
kidney
lipocalin
urine
biomarker

Study placed in the following topic categories:
Azotemia
Hydronephrosis
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Uremia
Emergencies
Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:
Azotemia
Renal Insufficiency
Disease Attributes
Hydronephrosis
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Uremia
Emergencies
Kidney Failure, Acute
Kidney Diseases
Renal Insufficiency, Acute
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009