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

NCT03057457 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 530

Last updated 2017-03-31

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Injury

Interventions

DEVICE

NGAL Test

The purpose of this study is to demonstrate that BioPorto Diagnostic's NGAL test is able to assist in determining the risk for acute kidney injury for patients who have been admitted to the intensive care unit.

Sponsors & Collaborators

  • BioPorto Diagnostics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2017-12-31
Completion
2018-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03057457 on ClinicalTrials.gov