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 early · Not applicable

Conditions studied: Sepsis, Acute Kidney Injury, Septic Shock

In brief

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.

Key facts

Study ID: NCT04434209
Run by: BioMérieux
People needed: 19
Starts: 2021-01-19
Expected to finish: 2022-02-14
Last updated by the study team: 2026-03-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinical diagnosis of sepsis or septic shock.
Admission to the ICU or planned admission to the ICU with an expected stay of 72 hours or more after enrollment in the same hospital.
Expected to have indwelling urinary catheter placed and kept until at least 48 hours after enrollment.
Written informed consent.

You may not qualify if…

Women with known pregnancy, prisoners or institutionalized individuals.
Previous renal transplant.
Stage 2 or 3 Acute Kidney Injury (AKI) at screening.
Receiving dialysis (either acute or chronic), or in imminent need of dialysis at enrollment.
Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2.
Known End Stage Renal Disease (ESRD) or history of active nephrotic syndrome within the last 3 months.
Known Stage 2-3 AKI within last 2 weeks.
Terminally ill (defined as expectation of death within 6 months), has a do not resuscitate order that would restrict protocol-required procedures, or is being admitted only for palliative care.
History of solid organ transplant and receiving calcineurin inhibitors.
Documented serious allergy (i.e. anaphylaxis) to vancomycin, aminoglycosides, penicillins, or cephalosporins (intravenous or oral).
Known current serum total bilirubin > 4mg/dL.
Subjects already included in an observational study can be co-enrolled in LAPIS. Subjects already included in an interventional study may be enrolled with pre-approval of the sponsor according to the following rules:
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.
Subjects with laboratory confirmed COVID-19 infection as the primary reason for hospital admission.
Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

LSU Health Sciences Center, 1541 Kings Highway — Shreveport, Louisiana, United States
Brigham and Womens Hospital, 75 Francis Street — Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, 1275 York Avenue — New York, New York, United States
AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10 — Bruges, West-Vlaanderen, Belgium
Hôpital Erasme, Soins Intensifs, Route de Lennik 808 — Brussels, Belgium
CHU Angers, 4 Rue Larrey — Angers, Maine-et-Loire, France
Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque — Béthune, Pas-de-Calais, France
CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel — Dijon, France
Hopital Cochin, 27 Rue Du Faubourg Saint Jacques — Paris, France
University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110 — Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20 — Leipzig, Saxony, Germany
Universitatsklinikum Munster, Albert-Schweitzer-Campus 1 — Münster, Germany

Full record on ClinicalTrials.gov

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