NCT01573962CompletedNot Applicable
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Astute Medical, Inc.
- Enrollment
- 420
- Primary Endpoint
- A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Withdrawn
Not Applicable
Multi-disease Carrier Screening Test ValidationSpinal Muscular Atrophy (SMA)Carrier ScreeningGenetic TestingNCT01663584Natera, Inc.
Unknown
Not Applicable
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 TestAcute Kidney InjuryNCT04785391Astute Medical, Inc.500
Enrolling By Invitation
Not Applicable
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family MembersNeoplasmsHematologic NeoplasmsHealthy VolunteersNCT00071045National Heart, Lung, and Blood Institute (NHLBI)6,000
Completed
Not Applicable
Blood and Urine Sample Collection From Healthy VolunteersHealthyNCT05154409Evotec International GmbH100
Completed
Not Applicable
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked CigarettesLung CancerNCT00745160Memorial Sloan Kettering Cancer Center115