Nephroprotection for severe trauma patients with early urine signs of kidney stress
Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial
This trial tests whether giving an early nephroprotection bundle to adults with severe trauma and a urine biomarker showing kidney stress can reduce acute kidney injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 523 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 6 sites (Clermont-Ferrand and 5 other locations) |
| Trial ID | NCT06834633 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults with severe trauma (ISS >15) admitted within 6 hours who have an elevated urine NC score (>0.3) measured within 12 hours of ICU admission. Eligible patients are assigned to receive either standard care or a systematic nephrotection bundle-of-care initiated promptly after the biomarker result. The bundle follows guideline-recommended steps such as hemodynamic optimization, avoidance of nephrotoxins, and close urine/output and creatinine monitoring, applied early to try to stop reversible cellular kidney stress. Outcomes focus on preventing progression to acute kidney injury in the early post-trauma period and during the hospital stay.
Who should consider this trial
Good fit: Adults (≥18) with severe trauma (ISS >15) admitted to a participating trauma center within 6 hours who have an indwelling urinary catheter and an NC urine score >0.3 measured within 12 hours are the intended participants.
Not a fit: Patients already meeting clinical AKI criteria, those admitted more than 6 hours after injury, those without a urinary catheter, pregnant or breastfeeding patients, and those under legal restriction are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could lower the number and severity of acute kidney injury episodes after severe trauma by enabling earlier protective care.
How similar studies have performed: Randomized trials in major surgical patients have shown early nephroprotection bundles can reduce severe AKI within 72 hours, but their application specifically in severe trauma patients is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Patient with indwelling urinary catheter * High risk of AKI: measurement of NC score on fresh urine performed as soon as possible within 12 hours of admission to ICU and value \> 0.3. * 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).
Where this trial is running
Clermont-Ferrand and 5 other locations
- Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation — Clermont-Ferrand, France (Not_yet_recruiting)
- Centre hospitaler Annecy Genevois, Service de réanimation — Épagny, France (Not_yet_recruiting)
- Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation — La Tronche, France (Not_yet_recruiting)
- Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation — Lyon, France (Recruiting)
- Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation — Pierre-Bénite, France (Recruiting)
- Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Céline MONARD — Hospices Civils de Lyon
- Study coordinator: Céline MONARD
- Email: celine.monard@chu-lyon.fr
- Phone: 04 72 11 13 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.