AST-134 TURQUOISE

AST-134 TURQUOISE

Urine Sample Processing Study: Analysis of Fresh vs. Frozen Urine Samples from ICU Subjects

Protocol Number: AST-134

Protocol Version: Revision D

Version Date: 23 May 2022

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Study Investigators

• PI: Danielle Davison, MD
• Sub-I: Katrina Hawkins, MD
• Sub-I: Lynn Abell, MD
• Sub-I: Mustafa Al-Mashat, MD
• Sub-I: Yoosif Abdalla, MD

Study Objectives

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects (n ≥120) with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR CCL14 Test results.

Patient Population

See inclusion criteria below.

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 sample collection
• Urine 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
• Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
• Special populations, pregnant women, prisoners or institutionalized individuals