Status:
COMPLETED
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
Lead Sponsor:
Astute Medical, Inc.
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
21+ years
Brief Summary
This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).
Eligibility Criteria
Inclusion
- a.
- Males and females 21 years of age or older
- Receiving care in an intensive care unit
- Expected to remain in the ICU for at least 48 hours after enrollment
- Use of indwelling urinary catheter as standard care at the time of enrollment
- Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection
- First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria
- Written informed consent provided by patient or legally authorized representative (LAR)
Exclusion
- Prior kidney transplantation
- Comfort-measures-only status
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
- History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
- Special populations, pregnant women, prisoners or institutionalized individuals
- Patient meets any of the following:
- Active bleeding with an anticipated need for \> 4 units PRBC in a day
- Hemoglobin \< 7 g/dL
- Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT01868724
Start Date
June 1 2013
End Date
September 1 2014
Last Update
March 13 2015
Active Locations (21)
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1
Washington D.C., District of Columbia, United States, 20037
2
Gainesville, Florida, United States, 32610
3
Chicago, Illinois, United States, 60611
4
Chicago, Illinois, United States, 60637