Kidney shield: a simple care bundle may prevent organ failure after severe injury
NCT ID NCT06834633
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether a set of five kidney-protecting measures — given early to severe trauma patients identified as high-risk by a urine test — can reduce the chance of acute kidney injury. About 500 adults with severe injuries will be randomly assigned to receive either the bundle or standard care. The goal is to see if early, targeted action can prevent kidney damage within the first three days in the ICU.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a bundle of five kidney-protecting measures (avoiding nephrotoxic drugs, optimizing blood flow, controlling blood sugar, detecting muscle breakdown, monitoring kidney function)
- What this could lead to
- If it works, this could give hospitals a simple, targeted way to prevent kidney failure in severely injured patients, potentially saving lives and reducing long-term complications.
- What could go wrong
- The bundle requires significant resources to implement fully, and earlier trials in other settings may not translate to trauma patients. The test used to identify high-risk patients is not perfect, so some may be misclassified.
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
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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
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About 523 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adult patient (≥ 18 years) * Severe trauma patients (ISS score \> 15) admitted to a trauma center * Time between trauma and admission to trauma center \<6h * High risk of AKI: at least one NC score greater than 0.3 within 12 hours of admission to critical care (intensive care and continuous monitoring unit) * Affiliated with a social security scheme or beneficiary of a similar scheme * Consent signed by patient or close relative, or attestation signed by investigator in case of emergency Exclusion Criteria: * Adult under legal protection (guardianship, curators) * Persons deprived of their liberty by judicial or administrative decision * Patients taking part in other interventional research which may interfere with the research and which includes an exclusion period still in progress at the time of inclusion. * Pregnant or breast-feeding woman (diagnosis of pregnancy by plasma βHCG (Beta-Human Chorionic Gonadotropin) assay routinely performed as part of the blood test on admission to the outpatient department of a woman of childbearing age). * Patients with end-stage or severe chronic renal failure with Glomerular Filtration Rate (GFR) \< 30 milliliters/min/1.73m2 or chronic dialysis. * Anuric patients * Severe heart failure defined as Left Ventricular Ejection Fraction (LVEF) \<25%. * Patient moribund on admission with an estimated length of stay of less than 24 hours * Patient with AKI at time of randomization (developed prior to ICU admission or within the first 12 hours of ICU admission, before randomization).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
RECRUITINGClermont-Ferrand, 63100, France
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Centre hospitaler Annecy Genevois, Service de réanimation
RECRUITINGÉpagny, 74370, France
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Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
RECRUITINGLa Tronche, 38700, France
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Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
RECRUITINGSaint-Etienne, 42000, France
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Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
RECRUITINGLyon, 69003, France
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Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
RECRUITINGPierre-Bénite, 69310, France
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