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Kidney Week

Abstract: INFO17-TH

The LAPIS Trial: A Biomarker-Guided Implementation of Kidney-Sparing Care Measures to Prevent AKI in Sepsis Patients

Session Information

  • Informational Posters - I
    November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

Authors

  • Kellum, John A., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
  • Ronco, Claudio, University of Padova, IRRIV, San Bortolo Hospital, Vicenza, Italy
  • Guzzi, Louis Michael, Florida Hospital, Longwood, Florida, United States
  • Heskia, Fabienne, bioMérieux, Marcy l'Etoile, France
  • Toback, Seth, bioMérieux, Marcy l'Etoile, France
Description

Background
Sepsis associated acute kidney injury (SA-AKI) increases the risk of morbidity and mortality. A novel biomarker [TIMP-2/IGFBP-7] (NephroCheckÒ) is available to aid in the clinical evaluation of critically ill patients who are at increased risk for developing AKI.

Subjects and methods
LAPIS is a randomized, controlled, multicenter trial of adults with a clinical diagnosis of sepsis at risk of developing AKI. Sites in the USA and Europe will participate to the study, enrolling approximately 750 subjects.

Enrollment and testing:
Subjects will be randomized 1:1 into 1 of 2 arms:
Control arm: subjects will be assessed for AKI based on clinical criteria and standard of care (SOC) assessments. NephroCheck testing will be performed with results masked to the site.
Intervention arm: subjects will be assessed for AKI based on clinical criteria plus three NephroCheck tests during the first day following the clinical diagnosis of sepsis.

Patient management:
Subjects randomized to the Control arm will be treated according to the attending clinician’s clinical judgment and the site’s SOC for treating sepsis patients; all interventions will be recorded.

Subjects randomized to the Intervention arm will be treated based on test results:
Subjects with all three negative NephroCheck Test results will receive a Test Negative Sepsis Bundle (TNSB) which allows for less intensive monitoring and faster de-escalation of care than SOC.
Subjects with any positive NephroCheck Test result will receive a Kidney-Sparing Sepsis Bundle (KSSB) with 3 levels of care possible depending on the test results. Interventions are based upon the KDIGO Guidelines.

The primary endpoint will be a composite of death, dialysis or progression of 2 stages of AKI (stage 0 to stage 2 and stage 1 to stage 3) within 96 hours. We will assess the impact of the NephroCheck-guided KSSB and TNSB on AKI severity healthcare utilization. Additional endpoints will include hospital and ICU length of stay, 30-day readmission rates and other health-economic endpoints. The study is scheduled to begin enrollment in early 2020.

Funding

  • bioMeriuex Inc.