NCT04434209

A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)

Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: BioMérieux · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment. NOTE: Participants are no longer being recruited to this study.

Conditions

• Sepsis
• Acute Kidney Injury
• Septic Shock

Interventions

Type	Name	Description
DEVICE	Subject management guided by NephroCheck® test	NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
OTHER	Standard of Care	Standard of Care patient management

Timeline

• Start date: 2021-01-19
• Primary completion: 2022-02-14
• Completion: 2022-02-14
• First posted: 2020-06-16
• Last updated: 2026-03-06

Locations

12 sites across 4 countries: United States, Belgium, France, Germany

Regulatory

• FDA-regulated device study