NCT00786708

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

November 5, 2008

Last Update Submit

February 7, 2014

Conditions

AzotemiaRenal Insufficiency, ChronicRenal Failure, AcuteHydronephrosis

Keywords

renalkidneylipocalinurinebiomarkerAzotemiaRenal insufficiency, chronicRenal failure, acuteHydronephrosis

Outcome Measures

Primary Outcomes (1)

  • The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.

    Assessed retrospectively after patient is discharged

Secondary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.

You may qualify if:

  • A. Must be greater than or equal to 18 years of age
  • B. Must satisfy the following age and sex stratified serum creatinine levels:
  • men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
  • women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
  • men older than 50 with serum creatinine greater than 1.0mg/dl
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Charite University Medical Center

Berlin, Germany

Location

Related 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, 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.

    PMID: 22240130RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

AzotemiaRenal Insufficiency, ChronicAcute Kidney InjuryHydronephrosis

Condition Hierarchy (Ancestors)

UremiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyChronic DiseaseDisease Attributes

Study Officials

  • Thomas L. Nickolas, MD, MS

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Jonathan Barasch, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Department of Medicine, Nephrology

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2009

Study Completion

July 1, 2013

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

DE(1)US(2)