Acute Kidney Injury
Conditions
Keywords
Kidney Renal
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).
Interventions
None listed
Sponsors
Astute Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine. | Day 1-7 of enrollment | This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| None at this time | 10 months | There are no secondary outcomes measures planned at this time |
Countries
Austria, Belgium, Germany, Spain, United Kingdom, United States
Outcome results
None listed