Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury



Status:
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:7/16/2012
Start Date:September 2010
Contact:Karin Hughes, Ph.D.
Email:khughes@astutemedical.com
Phone:858-882-0466

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The purpose of this study is to collect blood and urine samples that may help identify and
validate biomarkers for the early detection and risk assessment of acute kidney injury
(AKI).


Inclusion Criteria:

Males and females 21 years of age or older;

Subjects enrolled (first sample collection) from ED or Floor admitted to the ICU within 24
hours of enrollment; Subjects enrolled from ICU admitted to the ICU within the 24 hours
prior to enrollment; Expected to remain in the ICU for at least 48 hours after enrollment;
Use of indwelling urinary catheter as standard care expected for at least 48 hours after
enrollment; At least one of the following acute conditions within 24 hours prior to
enrollment:

(Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)and/or Cardiovascular SOFA score of ≥ 1
(MAP < 70 mm Hg and/or any vasopressor required).

Patient (or authorized representative) able and willing to provide written informed
consent for study participation.

Exclusion Criteria:

Special populations including women with known pregnancy, prisoners or institutionalized
individuals;Previous renal transplantation;Known acutely worsening renal function prior to
enrollment (e.g., any category of RIFLE criteria. Already receiving dialysis (either acute
or chronic) or in imminent need of dialysis at the time of enrollment; Known infection
with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);Patient
meets any of the following:Active bleeding with an anticipated need for > 4 units
PRBC;Hemoglobin < 7 g/dL;Any other condition that in the physician's opinion would
contraindicate drawing serial blood samples for clinical study purposes.
We found this trial at
19
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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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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Philadelphia, PA
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9500 Gilman Dr
San Diego, California 92093
(858) 534-2230
University of California at San Diego UC San Diego is dedicated to the advancement of...
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San Diego, CA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Augusta, GA
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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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Baltimore, MD
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Boston, Massachusetts 02215
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Boston, MA
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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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Brooklyn, NY
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Chicago, IL
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508 Fulton Street
Durham, North Carolina 27705
919-286-0411
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Durham, NC
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Miami, FL
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Novi, Michigan 48374
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Novi, MI
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Phoenix, Arizona 85008
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Phoenix, AZ
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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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Pittsburgh, PA
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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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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Rochester, MN
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Washington, District of Columbia 20052
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Washington,
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