Clinical trial NCT03057457: The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
Official title: The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Injury
Lead sponsor: BioPorto Diagnostics
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care patients diagnosed at high risk for developing AKI.

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.

Detailed description: 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 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.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: Up to 7 days in ICU or until discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Kidney Care
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: