TerminatedNot Applicable

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)

Stopped: Highly improbable to reach recruitment objective due to impact of COVID-19 pandemic

United States, Belgium19 participantsStarted 2021-01-19

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Exclusion criteria

✕. Co-enrollment in LAPIS will not be allowed with investigational drug and device studies;
✕. Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor;
✕. Co-enrollment in LAPIS will not be allowed if co-enrollment is an exclusion criterion in the other study.

What they're measuring

Number of deaths, dialysis or progression of AKI

Timeframe: Enrollment to 72 hours

Trial details

NCT IDNCT04434209

SponsorBioMérieux

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-14

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