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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01209169
First received: September 23, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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).


Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

Further study details as provided by Astute Medical, Inc.:

Primary Outcome Measures:
  • Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI. [ Time Frame: 10/2010 to 2/2013 ] [ Designated as safety issue: No ]
    Primary outcome measure: Identification and Validation of Biomarkers from Acutely ill patients at risk for AKI. (N=744) Secondary outcomes including follow-up (N=890).


Enrollment: 890
Study Start Date: September 2010
Study Completion Date: February 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult ICU patients at risk for AKI.

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209169

  Hide Study Locations
Locations
United States, Arizona
Maricopa Intergrated Health System
Phoenix, Arizona, United States, 85008
United States, California
University of California San Diego
San Diego, California, United States, 92103-8781
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0254
Bruce W. Carter Department of Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States, 30909
United States, Illinois
University of Chicago Medical Center Section of Nephrology
Chicago, Illinois, United States, 60637
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Med. Center (BIDMC)
Boston, Massachusetts, United States, 02215
United States, Michigan
Providence Park Hospital
Novi, Michigan, United States, 48374
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Austria
University Clinic for Internal Medicine
Innsbruck, Austria, 6020
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
France
Edouard Herriot Hospital
Lyon, France, 69003
Marc Jacquet Hospital
Melun, France, 77000
Haut-Lévéque Hospital
Pessac, France, 33600
Germany
UZ Brussel
Brussel, Belgium, Germany, 1090
Ghent University Hospital
Ghent, Belgium, Germany, 9000
Universitätsklinikum Aachen
Aachen, Germany, 52074
Universitätsklinik Frankfurt am Main
Frankfurt, Germany, 60590
Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
Frankfurt, Germany, 60590
Otto-von-Guericke-Universitat Magdeburg
Madgeburg, Germany, 39120
Spain
Critical Care Center, Sabadell Hospital
Sabadell, Spain, 08208
Sweden
Karolinska University Hospital
Solna, Stockholm, Sweden, 17176
United Kingdom
Guy's and St. Thomas Hospital
London, England, United Kingdom, SE1 7EH
King's College Hospital
London, England, United Kingdom, SE5 9RS
Worthing Hospital
Worthing, West Sussex, United Kingdom, BN11 2DH
Sponsors and Collaborators
Astute Medical, Inc.
Investigators
Principal Investigator: John Kellum, MD Professor, Critical Care Medicine, University of Pittsburgh
  More Information

Publications:
Responsible Party: Astute Medical, Inc.
ClinicalTrials.gov Identifier: NCT01209169     History of Changes
Other Study ID Numbers: Sapphire
Study First Received: September 23, 2010
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Astute Medical, Inc.:
Kidney Renal

Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014