AzotemiaNCT00786708
Sensitivity and Specificity of NGAL in an Emergency Room Population
An observational study of Azotemia and Renal Insufficiency, Chronic, run by Columbia University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Azotemia, Renal Insufficiency, Chronic, Renal Failure, Acute
- How many people
- 2,304 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2006to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.
Who may be able to join
- Must be greater than or equal to 18 years of age
- 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
- All pts greater than or equal to 18 years of age without kidney failure defined by B
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population
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.
Read the 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.
- Keywords
- renal, kidney, lipocalin, urine, biomarker, Azotemia, Renal insufficiency, chronic, Renal failure, acute, Hydronephrosis
- Medical subject headings
- Azotemia, Renal Insufficiency, Chronic, Acute Kidney Injury, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.
Measured: 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.
Measured: Assessed retrospectively after patient is discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AzotemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Charite University, Berlin, Germany, Staten Island University Hospital
- Responsible party
- Principal investigator, Thomas Nickolas, Columbia University
- Investigators
- Thomas L. Nickolas, MD, MS, Principal investigator, Columbia UniversityJonathan Barasch, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786708
- Sponsor's protocol ID
- AAAC1584
- Status last verified
- Feb 2014
- First submitted
- 5 Nov 2008
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22240130
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population
- ClinicalTrials.gov ID
- NCT00786708
- Acronym / sponsor ID
- AAAC1584
- Keywords
- renal, kidney, lipocalin, urine, biomarker, Azotemia, Renal insufficiency, chronic, Renal failure, acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,304 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Abbott, Charite University, Berlin, Germany, Staten Island University Hospital
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital through the emergency room who meet the inclusion / exclusion criteria for this study.
Key inclusion criteria (7 listed)
- Must be greater than or equal to 18 years of age
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.
Time frame: Assessed retrospectively after patient is discharged
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Results publication: PubMed 22240130Nickolas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L. Nickolas, MD, MS principal investigator
Columbia University
Jonathan Barasch, MD, PhD principal investigator
Columbia University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Azotemia and Renal Insufficiency, Chronic, run by Columbia University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury. (time frame: Assessed retrospectively after patient is discharged). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.