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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)

NCT04434209 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-03-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • BioMérieux

    lead INDUSTRY

Principal Investigators

  • Hernando Gomez, MD, MPH · Center for Critical Care Nephrology, University of Pittsburgh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2022-02-14
Completion
2022-02-14
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434209 on ClinicalTrials.gov