NCT01294228

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,001 (actual)
• Sponsor: Abbott RDx Cardiometabolic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will be conducted in two phases. Phase One is specimen acquisition and subject diagnosis adjudication. Phase Two is biomarker testing. Phase One 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. Phase Two 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.

Conditions

• Acute Kidney Injury

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-04-01
• Completion: 2014-12-01
• First posted: 2011-02-11
• Last updated: 2017-02-02
• Results posted: 2017-02-02

Locations

28 sites across 2 countries: United States, Canada