The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
NCT ID: NCT03057457
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
530 participants
OBSERVATIONAL
2017-03-31
2018-02-28
Brief Summary
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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.
Detailed Description
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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 the 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. Enrollment is estimated to take approximately six months and the trial will be stopped when the Adjudication Panel has diagnosed at least 85 patients with AKI stage 2 or 3.
Each subject who is enrolled in the study will only have 4 blood draws as part of NGAL TestTM Trial with no additional study activities with the exception of data collection. The NGAL results will not be returned to the treating physician for use in the health management of the study subjects.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kidney Injury
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BioPorto Diagnostics
INDUSTRY
Responsible Party
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Locations
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Colorado Kidney Care
Denver, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Melanie Foster-Schwartz
Role: primary
Brock Katherine
Role: primary
Other Identifiers
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NGAL-001
Identifier Type: -
Identifier Source: org_study_id