Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU (REAL-ICU)
|ClinicalTrials.gov Identifier: NCT01294228|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : February 2, 2017
Last Update Posted : February 2, 2017
|Condition or disease|
|Acute Kidney Injury|
The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing.
Approximately 850 adults admitted to general ICUs will be enrolled within 12 hours of receipt of ICU admission orders. Study specific whole blood and urine specimens will be collected.
There is an Adjudication Committee for this study. This committee is comprised of qualified, board-certified nephrologists.
During Phase Two, the plasma specimens will be divided amongst three clinical sites representative of the intended end users of this assay, and tested under a separate testing protocol.
|Study Type :||Observational|
|Actual Enrollment :||1001 participants|
|Official Title:||Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||December 2014|
- 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. [ Time Frame: Prior to or within 72 hours. ]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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294228
Show 28 Study Locations
|Principal Investigator:||John Kellum, MD||University of Pittsburgh|