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

Completed

Conditions studied: Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT01209169

Run by

Astute Medical, Inc.

People needed

890

Starts

2010-09-01

Expected to finish

2013-02-01

Last updated by the study team

2013-02-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maricopa Intergrated Health System — Phoenix, Arizona, United States
• University of California San Diego — San Diego, California, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Bruce W. Carter Department of Veterans Affairs Medical Center — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Joseph M. Still Research Foundation, Inc. — Augusta, Georgia, United States
• University of Chicago Medical Center Section of Nephrology — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Med. Center (BIDMC) — Boston, Massachusetts, United States
• Providence Park Hospital — Novi, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Durham VA Medical Center — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University Clinic for Internal Medicine — Innsbruck, Austria
• University of Alberta — Edmonton, Alberta, Canada
• Edouard Herriot Hospital — Lyon, France
• Marc Jacquet Hospital — Melun, France
• Haut-Lévéque Hospital — Pessac, France
• UZ Brussel — Brussel, Belgium, Germany

Full record on ClinicalTrials.gov

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