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

NCT03057457 | Unknown FDA Device

• 1 other identifier: NGAL-001
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  To demonstrate that the sum of sensitivity and specificity is greater than 1 using a cutoff of 140 ng/mL when compared to the primary clinical endpoint AKI as adjudicated KDIGO Stage 2/3 AKI

  Up to 7 days in ICU or until discharge

Study Arms (1)

Kidney Injury

Device: NGAL Test

Interventions

NGAL Test DEVICE

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.

Kidney Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensive care patients diagnosed at high risk for developing AKI.

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

Sponsors & Collaborators

• BioPorto Diagnostics: lead

Study Sites (2)

Colorado Kidney Care

Denver, Colorado, 80218, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Central Study Contacts

Patsy Folio

CONTACT

480-735-9035; patsy.folio@precisionformedicine.com

Natalia Escuti, MD

CONTACT

818 481 2248; natalia.escuti@precisionformedicine.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)