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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astute Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01573962
First received: April 6, 2012
Last updated: September 23, 2013
Last verified: September 2013

April 6, 2012
September 23, 2013
April 2012
December 2012   (final data collection date for primary outcome measure)
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury [ Time Frame: 04/1/2012 to 3/29/13 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01573962 on ClinicalTrials.gov Archive Site
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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
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult patients at risk of AKI.

Acute Kidney Injury
Not Provided
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01573962
Topaz
No
Astute Medical, Inc.
Astute Medical, Inc.
Not Provided
Principal Investigator: John Kellum, Ph.D. Professor, Critical Care Medicine, University of Pittsburgh
Astute Medical, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP