A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
1 other identifier
observational
420
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Shorter than P25 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 15, 2014
September 1, 2013
8 months
April 6, 2012
October 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Adult patients at risk of AKI.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angels, California, 90095, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Gainesville, Florida, 32610-0254, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Minneapolis, Minnesota, 55415, United States
Unknown Facility
Missoula, Montana, 59802, United States
Unknown Facility
Rochester, New York, 14621, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Akron, Ohio, 44309, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15212, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15261, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 24559465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Kellum, Ph.D.
Professor, Critical Care Medicine, University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 15, 2014
Record last verified: 2013-09