Trial Outcomes & Findings for Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU (NCT NCT01294228)

NCT ID: NCT01294228

Last Updated: 2017-02-02

Results Overview

The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.

• Recruitment status: COMPLETED
• Target enrollment: 1001 participants
• Primary outcome timeframe: Prior to or within 72 hours.
• Results posted on: 2017-02-02

Participant Flow

Participant milestones

Measure	Clinical Study Population All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
Overall Study STARTED	1001
Overall Study COMPLETED	1001
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU

Baseline characteristics by cohort

Measure	Clinical Study Population n=871 Participants All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
Age, Continuous	61.7 years STANDARD_DEVIATION 15.7 • n=93 Participants
Gender Female	375 Participants n=93 Participants
Gender Male	496 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	62 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	809 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	16 Participants n=93 Participants
Race (NIH/OMB) Asian	31 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	187 Participants n=93 Participants
Race (NIH/OMB) White	625 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=93 Participants
Region of Enrollment Canada	81 participants n=93 Participants
Region of Enrollment United States	790 participants n=93 Participants

PRIMARY outcome

Timeframe: Prior to or within 72 hours.

Population: Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.

The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.

Outcome measures

Measure	Clinical Study Population n=782 Participants All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.	0.671 Probability Interval 0.609 to 0.733

Adverse Events

Clinical Study Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

Alere San Diego

Phone: 1-858-805-4808

Email: william.arnold@alere.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60