Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 1:00 PM
Study NCT ID:
NCT00786708
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2008-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity and Specificity of NGAL in an Emergency Room Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053099', 'term': 'Azotemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D006869', 'term': 'Hydronephrosis'}], 'ancestors': [{'id': 'D014511', 'term': 'Uremia'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-07', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.', 'timeFrame': 'Assessed retrospectively after patient is discharged'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal', 'kidney', 'lipocalin', 'urine', 'biomarker', 'Azotemia', 'Renal insufficiency, chronic', 'Renal failure, acute', 'Hydronephrosis'], 'conditions': ['Azotemia', 'Renal Insufficiency, Chronic', 'Renal Failure, Acute', 'Hydronephrosis']}, 'referencesModule': {'references': [{'pmid': '22240130', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA. Must be greater than or equal to 18 years of age\n\nB. Must satisfy the following age and sex stratified serum creatinine levels:\n\n1. men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl\n2. women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl\n3. men older than 50 with serum creatinine greater than 1.0mg/dl\n4. women older than 50 with serum creatinine greater than 0.8mg/dl\n\nC. All pts greater than or equal to 18 years of age without kidney failure defined by B'}, 'identificationModule': {'nctId': 'NCT00786708', 'briefTitle': 'Sensitivity and Specificity of NGAL in an Emergency Room Population', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population', 'orgStudyIdInfo': {'id': 'AAAC1584'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NGAL', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University Medical Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Thomas L. Nickolas, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Jonathan Barasch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Staten Island University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Department of Medicine, Nephrology', 'investigatorFullName': 'Thomas Nickolas', 'investigatorAffiliation': 'Columbia University'}}}}