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A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

Sponsor
Astute Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01573962
Collaborator
(none)
420
Enrollment
23
Locations
8
Duration (Months)
18.3
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this sample collection study is to collect blood and urine samples. This study is observational and will have no impact on the medical management of the subject.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    420 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury [04/1/2012 to 3/29/13]

    Eligibility Criteria

    Criteria

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

    • Males and females 21 years of age or older

    • Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission

    • Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment

    • Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 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 documented within 24 hours prior to enrollment

    • Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)

    • Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required

    • Subject (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 moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3

    • 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)

    • Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda California United States 92354
    2 Los Angels California United States 90095
    3 Washington District of Columbia United States 20037
    4 Gainesville Florida United States 32610-0254
    5 Tampa Florida United States 33606
    6 Idaho Falls Idaho United States 83404
    7 Chicago Illinois United States 60611
    8 Chicago Illinois United States 60637
    9 Shreveport Louisiana United States 71103
    10 Baltimore Maryland United States 21201
    11 Ann Arbor Michigan United States 48109
    12 Minneapolis Minnesota United States 55415
    13 Missoula Montana United States 59802
    14 Bronx New York United States 10467
    15 Rochester New York United States 14621
    16 Durham North Carolina United States 27705
    17 Akron Ohio United States 44309
    18 Portland Oregon United States 97239
    19 Pittsburgh Pennsylvania United States 15212
    20 Pittsburgh Pennsylvania United States 15261
    21 Nashville Tennessee United States 37232
    22 Houston Texas United States 77030
    23 Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Astute Medical, Inc.

    Investigators

    • Principal Investigator: John Kellum, Ph.D., Professor, Critical Care Medicine, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astute Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT01573962
    Other Study ID Numbers:
    • Topaz
    First Posted:
    Apr 10, 2012
    Last Update Posted:
    Oct 15, 2014
    Last Verified:
    Sep 1, 2013
    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 Oct 15, 2014