Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU (REAL-ICU)
This is a multi-center, prospective, observational study of patients that are admitted to the intensive care unit (ICU). This study does not include any treatment or intervention and it is considered Nonsignificant Risk.
Acute Kidney Injury
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Rapid Evaluation of Acute Kidney Injury With NGAL in Acutely Ill Patients in the ICU|
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294228
Show 28 Study Locations
|Principal Investigator:||John Kellum, MD||University of Pittsburgh|