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

February 21, 2013 updated by: Astute Medical, Inc.
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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

890

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients at risk for AKI.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Novel Biomarkers From Acutely ill Patients at Risk for AKI.
Time Frame: 10/2010 to 2/2013
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).
10/2010 to 2/2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Kellum, MD, Professor, Critical Care Medicine, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAPPHIRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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