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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
    • Los Angels, California, United States, 90095
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
  • Florida
    • Gainesville, Florida, United States, 32610-0254
    • Tampa, Florida, United States, 33606
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
  • Illinois
    • Chicago, Illinois, United States, 60637
    • Chicago, Illinois, United States, 60611
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
  • Montana
    • Missoula, Montana, United States, 59802
  • New York
    • Bronx, New York, United States, 10467
    • Rochester, New York, United States, 14621
  • North Carolina
    • Durham, North Carolina, United States, 27705
  • Ohio
    • Akron, Ohio, United States, 44309
  • Oregon
    • Portland, Oregon, United States, 97239
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
    • Pittsburgh, Pennsylvania, United States, 15212
  • Tennessee
    • Nashville, Tennessee, United States, 37232
  • Texas
    • Houston, Texas, United States, 77030
  • Virginia
    • Richmond, Virginia, United States, 23298

Participation Criteria

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 patients at risk of AKI.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astute Medical, Inc.
• Investigators: Principal Investigator: John Kellum, Ph.D., Professor, Critical Care Medicine, University of Pittsburgh

Publications and helpful links

General Publications

• Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 6, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Kidney Renal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: Topaz