Nephroprotection in Severe Trauma Patients With Kidney Stress (NCT06834633) | Clinical Trial Compass
RecruitingNot Applicable
Nephroprotection in Severe Trauma Patients With Kidney Stress
France523 participantsStarted 2025-07-09
Plain-language summary
Acute Kidney Injury (AKI) occurs in 24% of trauma patients, and is even more common in those with severe trauma. It is a major contributor to morbidity and mortality in trauma. Diagnosis of AKI is based on elevated serum creatinine and decreased urine output, two functional markers already indicating the presence of a significant kidney function impairment. Earlier detection of kidney stress, at a preclinical stage when cellular modifications are still reversible, could reduce the occurrence of AKI episodes if nephroprotective measures are rapidly implemented.
Several randomized controlled trials have shown that early implementation of such a nephroprotection bundle-of-care in patients at risk of AKI after major surgery reduces the incidence of severe AKI within 72 hours. Although its use is supported by international guidelines, this nephroprotection bundle-of-care is rarely implemented in its totality, due to the significant financial and human resources required for its full implementation.
The Nephrocheck® (NC) test is a urine test for which a result \> 0.3 is predictive of AKI development. It might enable early identification of trauma patients at risk of AKI, so that implementation of the nephroprotection bundle-of-care could be targeted solely at those high-risk patients.
Thus, the investigators hypothesize that in a population of severe trauma patients (ISS score\>15) at risk of AKI (defined by a NC on Intensive Care Unit (ICU) admission \> 0.3), early implementation of a nephroprotection bundle-of-care would reduce the risk of AKI occurring within 3 days of ICU admission, compared with standard-of-care management. This study will compare the occurrence of AKI in these two groups in a multicenter randomized controlled trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on protecting the kidneys in severe trauma patients — given my specific injuries, does my doctor think I'm at high enough risk for acute kidney injury within the first few days in the ICU to make this study relevant to me?
2Since this trial is listed as 'Phase NA,' it may involve a care protocol or intervention that doesn't fit the standard drug-trial phases — can my doctor explain exactly what is being done differently in this study compared to the standard care I'd receive anyway?
3The trial is measuring whether patients develop acute kidney injury within 3 days of ICU admission, which is a very short window — how would my participation in this study affect the monitoring and treatment decisions being made for me during those critical first 72 hours?
4Since this trial is actively recruiting right now, could joining it delay or complicate any urgent treatment decisions that need to happen quickly after a severe trauma?
5What would happen to my kidney care if I chose not to join this trial — is there a standard-of-care approach my doctor would follow instead, and how does it compare to what this study is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients developing an AKI episode within 3 days after ICU admission.