Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT01868724
• Lead Sponsor: Astute Medical, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-21
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-04
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
None at this time	10 months	There are no secondary outcomes measures planned at this time