Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Astute Medical, Inc.0 sites362 target enrollmentJune 2013

ConditionsAcute Kidney Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Kidney Injury
Sponsor: Astute Medical, Inc.
Enrollment: 362
Primary Endpoint: Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

September 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.

Time Frame: 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.