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Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Sponsor
Astute Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01868724
Collaborator
(none)
362
Enrollment
21
Locations
15
Duration (Months)
17.2
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    362 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Sep 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine. [Day 1-7 of enrollment]

      This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.

    Secondary Outcome Measures

    1. None at this time [10 months]

      There are no secondary outcomes measures planned at this time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington District of Columbia United States 20037
    2 Gainesville Florida United States 32610
    3 Chicago Illinois United States 60611
    4 Chicago Illinois United States 60637
    5 Baltimore Massachusetts United States 21201
    6 Ann Arbor Michigan United States 48109
    7 Durham North Carolina United States 27705
    8 Akron Ohio United States 44304
    9 Cleveland Ohio United States 44195
    10 Pittsburgh Pennsylvania United States 15212
    11 Pittsburgh Pennsylvania United States 15261
    12 Nashville Tennessee United States 37232
    13 Innsbruck Austria 6020
    14 Brussels Belgium 1090
    15 Ghent Belgium 9000
    16 Frankfurt Germany 60590
    17 Madgeburg Germany 39120
    18 Sabadelle Spain 08208
    19 London United Kingdom E1 1BB
    20 London United Kingdom SE1 7EH
    21 West Sussex United Kingdom BN11 2DH

    Sponsors and Collaborators

    • Astute Medical, Inc.

    Investigators

    • Principal Investigator: Lakhmir S Chawla, M.D., George Washington University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astute Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT01868724
    Other Study ID Numbers:
    • Ruby
    First Posted:
    Jun 4, 2013
    Last Update Posted:
    Mar 13, 2015
    Last Verified:
    Sep 1, 2014
    Keywords provided by Astute Medical, Inc.
    Kidney Renal
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Mar 13, 2015