Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:March 2011
End Date:April 2013

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This is a multi-center, prospective, observational study of patients that are admitted to
the intensive care unit (ICU). This study does not include any treatment or intervention
and it is considered Nonsignificant Risk.


The study will be conducted in two phases. Phase One is specimen acquisition and subject
diagnosis adjudication. Phase Two is biomarker testing.

Phase One

Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of
receipt of ICU admission orders. Study specific whole blood and urine specimens will be
collected.

There is an Adjudication Committee for this study. This committee is comprised of
qualified, board-certified nephrologists.

Phase Two

During Phase Two, the plasma specimens will be divided amongst three clinical sites
representative of the intended end users of this assay, and tested under a separate testing
protocol.

Inclusion Criteria:

- Subjects must be 21 years of age or older.

- Subjects must be admitted to an Intensive Care Unit (medical or surgical) and must be
enrolled into this study within 12 hours of receipt of ICU admission orders.

- Subjects must be assessed as likely to be alive in the ICU for a minimum of 48 hours
after enrollment.

- The following plasma/serum creatinine values must be available:

- Subjects that are admitted to the ICU following an elective surgery or procedure
must have at least one pre-surgical/ pre-procedure creatinine value obtained in the 7
days prior to presentation to the ICU.

- Subjects that are admitted to the ICU for any reason other than following an elective
surgery or procedure must have at least one creatinine value obtained greater than 7
days and up to 6 months prior to presentation to the ICU.

Exclusion Criteria

- Subjects either receiving or in imminent need of Renal Replacement Therapy.

- Subjects with evidence of chronic kidney disease stages 4 and 5 as evidenced by a
pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 (according to the
4-variable MDRD22).

- Subjects with any obstructive uropathy at the time of presentation to the ICU.

- Subjects with any known urothelial, urological or kidney malignancies.

- Subjects that have had any urologic procedure or surgery immediately prior to
admission to the ICU.

- Subjects that have had any renal transplant or nephrectomy.

- Subjects that have had cardiovascular surgery involving cardiopulmonary bypass within
the previous 7 days.

- Subjects that have participated in an interventional clinical study within the
previous 30 days including studies with any investigational and non-investigational
drugs.

- The inability to obtain written Informed Consent from the subject or an authorized
representative.

- Subjects that have been previously enrolled in this study during a prior admission to
the ICU.
We found this trial at
25
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Clearwater, Florida 33765
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1200 N State St Pmb 305
Los Angeles, California 90033
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Everett, Washington 98201
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Kansas City, Kansas
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1 Gustave L. Levy Pl
New York, New York 10029
(212) 241-6500
The Mount Sinai Hospital Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92093
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San Francisco, California 94110
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Stony Brook, New York 11501
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