Clinical trial NCT01573962: A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
Official title: A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Kidney Renal
Lead sponsor: Astute Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 420
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients at risk of AKI.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
timeFrame: 04/1/2012 to 3/29/13
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
state: California
city: Los Angels
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Missoula
country: United States
state: Montana
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Professor, Critical Care Medicine, University of Pittsburgh
name: John Kellum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.