Validation of The NEPHROCLEARTM CCL14 Test in the Intensive Care Unit (ICU) for Risk Assessment of Persistent Severe Acute Kidney Injury

Overview

About this study

The purpose of this study is to to collect urine samples to validate the NEPHROCLEARTM CCL14 Test in intensive care unit (ICU) patients with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (Stage 3 AKI lasting > 72 hours) within 48 hours of patient assessment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

Individuals under 21 years of age.
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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Kianoush Banaei Kashani, M.D., M.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Kianoush Banaei Kashani, M.D., M.S.

Closed for enrollment

More information

Publications

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