Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Astute Medical

Status: Completed

Conditions: Acute Kidney Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT01868724

Ruby

Details and patient eligibility

About

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).

Enrollment: 362 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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