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Can a simple urine test prevent kidney failure in sepsis?

NCT ID NCT04434209

Disease control Sponsor: BioMérieux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a urine biomarker test (NephroCheck) to guide treatment could reduce kidney injury, dialysis, or death in sepsis patients. The trial planned to enroll many participants but was stopped early after only 19 people joined. The idea was to catch kidney stress early and adjust care, but the early termination means we cannot draw firm conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NephroCheck® test (a urine biomarker test to assess kidney stress)
What this could lead to
If successful, this approach could help doctors identify sepsis patients at risk of kidney injury earlier and tailor care to prevent kidney damage.
What could go wrong
The trial was terminated early with only 19 participants, so results are very limited. The test may not improve outcomes in larger or different patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

19 people

The number who actually took part.

Started

Jan 2021

Finished

Feb 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. Co-enrollment in LAPIS will not be allowed with investigational drug and device studies; 2. Studies may be allowed if AKI or kidney function is not an endpoint with pre-approval of the LAPIS sponsor; 3. 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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Sepsis Septic shock

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10

    Bruges, West-Vlaanderen, 8000, Belgium

  • Brigham and Womens Hospital, 75 Francis Street

    Boston, Massachusetts, 02115, United States

  • CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel

    Dijon, 21079, France

  • CHU Angers, 4 Rue Larrey

    Angers, Maine-et-Loire, 49100, France

  • Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque

    Béthune, Pas-de-Calais, 62408, France

  • Hopital Cochin, 27 Rue Du Faubourg Saint Jacques

    Paris, 75679, France

  • Hôpital Erasme, Soins Intensifs, Route de Lennik 808

    Brussels, 1070, Belgium

  • LSU Health Sciences Center, 1541 Kings Highway

    Shreveport, Louisiana, 71130, United States

  • Memorial Sloan Kettering Cancer Center, 1275 York Avenue

    New York, New York, 10065, United States

  • Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20

    Leipzig, Saxony, 04103, Germany

  • Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

    Münster, 48149, Germany

  • University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110

    Heidelberg, Baden-Wurttemberg, 69120, Germany

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