The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population

Status unconfirmed

Conditions studied: Kidney Injury

In brief

The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for testing on automated clinical chemistry analyzer. The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day of patient assessment in patients in the intensive care unit (ICU) who are hypotensive (MAP\<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of persistent (≥2 days) stage 2 or 3 AKI. The Primary Objective for this clinical trial is to validate that the NGAL test using a cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL test shows clinical performance in predicting persistent moderate or severe acute kidney injury during any contiguous 2 day interval. It is anticipated that up to 20 Clinical Sites in US will participate in the trial. The study sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are admitted to hospital in an ICU or critical care setting. Patients will receive their clinical standard of care including standard laboratory and other testing as requested by each subject's physician.

Key facts

Study ID

NCT03057457

Run by

BioPorto Diagnostics

People needed

530

Starts

2017-03-01

Expected to finish

2018-02-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Subjects should be enrolled within 24 hrs. of ICU admission, from ED or floor within 24 hrs. of ICU admission or if the subject is from another ICU no more than 24 hrs. from presentation.
• Within 24 hrs. prior to enrollment the subject's
• o Cardiovascular SOFA score of >= 1(MAP<70 mmHg and/or receiving any vasopressor support
• Subject or representative written informed consent
• Subject > 18 years of age

You may not qualify if…

• If the subject is part of a special population (pregnancy, prisoners)
• If the subject has received a previous renal transplantation
• If the subject has been diagnosed with moderate to severe AKI prior to enrollment as defined by the treating physician (KDIGO Stage 2/3, RIFLE-I or RIFLE-F/AKIN 2 or AKIN 3) ,
• If the subject is currently on dialysis or in imminent need of dialysis at the time of enrollment
• The subject has been diagnosed with HIV or Hepatitis
• The subject has been diagnosed with Chronic Kidney disease without baseline value - CKD stage 4-5
• If the patient is on palliative care

Where it is running

• Colorado Kidney Care — Denver, Colorado, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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