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Urine test may spot kidney danger early in septic shock

NCT ID NCT03547414

Diagnosis Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether a urine test called Nephrocheck can predict which patients with septic shock will develop severe acute kidney injury. The test measures two markers of kidney damage (TIMP2 and IGFBP7). Researchers will analyze data from previous studies involving adults with septic shock and mild-to-moderate kidney injury to see if the test can identify those at risk of worsening to severe kidney failure within 72 hours. If accurate, this could help doctors intervene sooner.

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 (urinary TIMP2 and IGFBP7 measurement)
What this could lead to
If successful, this test could help doctors identify septic shock patients at high risk of severe kidney damage, allowing earlier and more targeted treatment.
What could go wrong
This is a small, observational study re-analyzing previous data, so results may not be definitive or apply to all patients. The test is still being validated and may not improve outcomes.

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.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients with Septic shock (according to Bone's criteria) within 6 hours of introduction of catecholamines

Ages

18 years and older

Sex

Anyone

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: * Age 18 or over * Septic shock (according to Bone's criteria) within 4 hours of introduction of catecholamines * AKI, characterized by a KDIGO score ≥ 1 * Social security coverage Exclusion Criteria: * AKI requiring emergency RRT (in the critical care physician's opinion). * Anuria * Stage 4-5 chronic kidney failure with a GFR below 30 ml/min. * Rapidly progressing renal disorders (glomerulonephritis, HUS, blockage, etc.) * Obstructive AKI * Probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis) * Pregnancy or breastfeeding * Legal guardianship or lack of social security coverage. * Cardiocirculatory arrest * Life expectancy \<48 hours. * Child C cirrhosis * Prior occurrence of AKI during the current hospital stay * Transplantation * Subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion

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Conditions

The condition(s) this trial relates to.

acute kidney injury toxic shock syndrome

As listed by the trial registrant

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

Acute kidney injury Septic shock

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Amiens-Picardie

    RECRUITING

    Amiens, 80054, France

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