Identification and Validation of Biomarkers of Acute Kidney Injury Recovery



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:21 - Any
Updated:11/8/2014
Start Date:June 2013
Contact:Karin Hughes, Ph.D.
Email:khughes@astutemedical.com
Phone:858-500-7044

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This study is to collect blood and urine samples to help identify and validate protein
biomarkers of recovery from moderate or severe acute kidney injury (AKI).


Inclusion Criteria:a.

- Males and females 21 years of age or older

- Receiving care in an intensive care unit

- Expected to remain in the ICU for at least 48 hours after enrollment

- Use of indwelling urinary catheter as standard care at the time of enrollment

- Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the
first sample collection

- First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria

- Written informed consent provided by patient or legally authorized representative
(LAR)

Exclusion Criteria:

- Prior kidney transplantation

- Comfort-measures-only status

- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis
at the time of enrollment

- History of human immunodeficiency virus (HIV) or hepatitis virus (based upon
available medical records) infections (NOTE: HIV or hepatitis testing need not be
performed for enrollment in this study.)

- Special populations, pregnant women, prisoners or institutionalized individuals

- Patient meets any of the following:

- Active bleeding with an anticipated need for > 4 units PRBC in a day

- 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
12
sites
1729
mi
from 91732
Chicago, IL
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2040
mi
from 91732
Akron, OH
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1932
mi
from 91732
Ann Arbor, MI
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2304
mi
from 91732
Baltimore, MA
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1729
mi
from 91732
Chicago, IL
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2032
mi
from 91732
Cleveland, OH
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2202
mi
from 91732
Durham, NC
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2103
mi
from 91732
Gainesville, FL
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1763
mi
from 91732
Nashville, TN
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2119
mi
from 91732
Pittsburgh, PA
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2119
mi
from 91732
Pittsburgh, PA
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2281
mi
from 91732
Washington,
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