Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Columbia University Abbott Charite University, Berlin, Germany Staten Island University Hospital |
---|---|
Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00786708 |
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: | Cohort, Prospective |
Official Title: | Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population |
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.
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:
Contact: Thomas L Nickolas, MD, MS | tln2001@columbia.edu | |
Contact: Jonathan Barasch, MD, PhD | jmb4@columbia.edu |
United States, New York | |
Staten Island University Hospital | Recruiting |
Staten Island, New York, United States, 10305 | |
Principal Investigator: Subodh J Saggi, MD, MPH |
Principal Investigator: | Thomas L. Nickolas, MD, MS | Columbia University Medical Center |
Principal Investigator: | Jonathan Barasch, MD, PhD | Columbia University Medical Center |
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 |
renal kidney lipocalin urine biomarker |
Azotemia Hydronephrosis Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Uremia |
Emergencies Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Kidney Failure |
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 |