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

Completed

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT01573962

Run by

Astute Medical, Inc.

People needed

420

Starts

2012-04-01

Expected to finish

2012-12-01

Last updated by the study team

2014-10-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Study site — Loma Linda, California, United States
• Study site — Los Angels, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Missoula, Montana, United States
• Study site — Rochester, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.