Trauma; ComplicationsNephroTraumaNCT06834633
Nephroprotection in Severe Trauma Patients With Kidney Stress
A study testing Standard-of-care and Systematic nephroprotection bundle-of-care in people with Trauma; Complications, run by Hospices Civils de Lyon at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma; Complications
- What is being tested?
- Standard-of-care and Systematic nephroprotection bundle-of-care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- 6 sitesFrance
- Study dates
- 9 Jul 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
Clermont-Ferrand, 63100
Benjamin RIEU, MD, 04 73 75 05 06 ext. +33, brieu@chu-clermontferrand.fr
Benjamin RIEU, MD
- Recruiting
Centre hospitaler Annecy Genevois, Service de réanimation
Épagny, 74370
Albrice LEVRAT, MD, 04 50 63 60 30 ext. +33, alevrat@ch-annecygenevois.fr
Albrice LEVRAT, MD
- Recruiting
Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
La Tronche, 38700
Thibaut TROUVE-BUISSON, MD, 04 76 76 52 95 ext. +33, ttrouvebuisson@chu-grenoble.fr
Thibaut TROUVE-BUISSON, MD
- Recruiting
Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
Lyon, 69003
Céline MONARD, MD, 04 72 11 13 27 ext. +33, celine.monard@chu-lyon.fr
Céline MONARD, MD
- Recruiting
Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
Pierre-Bénite, 69310
Jean-Stéphane DAVID, MD, PhD, 04 78 86 57 56 ext. +33, jean-stephane.david@chu-lyon.fr
Jean-Stéphane DAVID, MD, PhD
- Recruiting
Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
Saint-Etienne, 42000
Jérôme MOREL, MD, PhD, 04 77 82 83 29 ext. +33, jerome.morel@chu-st-etienne.fr
Jérôme MOREL, MD, PhD
About this study
Official title: Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Trauma; Complications
- Being tested
- Standard-of-care, Systematic nephroprotection bundle-of-care
- Keywords
- Severe trauma, Acute Kidney Injury, Nephroprotection bundle-of-care, Biomarker
- Medical subject headings
- Wounds and Injuries, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-careOther
Management according to current ICU practices
Systematic nephroprotection bundle-of-careOther
The nephroprotection bundle-of-care includes 5 components:
- Prevention of drugs' nephrotoxicity
- Hemodynamic optimization, for 24h
- Blood glucose control and avoidance of hyperglycemia
- Early detection of rhabdomyolysis
- Monitoring of renal function
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Other | Patients in the observational group will be managed according to the unit's standard-of-care, as in the control group, but without investigators knowing the patient's risk of AKI (NC score not known) Receives: Other: Standard-of-care |
| Control group: Standard-of-care | Other | Patients at risk of AKI (NC>0.3) randomized in the control group will be managed according to the unit's standard-of-care. Receives: Other: Standard-of-care |
| Intervention group: nephroprotection bundle-of-care | Experimental | Patients at risk of AKI (NC>0.3) randomized in the intervention group will receive the systematic and complete application of a nephroprotection bundle-of-care for three days following ICU admission. Receives: Other: Systematic nephroprotection bundle-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing an AKI episode within 3 days after ICU admission.
AKI will be defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria, either by a drop in urine output (oliguria < 0.5ml/kg/h for 6h) and/or a rise in serum creatinine (1.5x baseline or increase of 26.5 µmol/l).
Measured: During 3 days from ICU admission.
Secondary outcomes (14)
Proportion of patients with AKI within 7 days of ICU admission
AKI will be defined according to KDIGO criteria, either by a drop in urine output (oliguria < 0.5ml/kg/h for 6h) and/or a rise in serum creatinine (1.5x baseline or increase of 26.5 µmol/l).
Measured: During 7 days from ICU admission
Proportion of patients with severe AKI within 3 days of ICU admission
Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Measured: During 3 days from ICU admission
Proportion of patients with severe AKI within 7 days of ICU admission
Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Measured: During 7 days from ICU admission
Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28
MAKE 28 is defined by the occurrence of one event among (1) death before day 28 after ICU admission, (2) requirement of renal replacement therapy on day 28 or (3) incomplete renal recovery on day 28.
Measured: At 28 days after ICU admission
Proportion of patients with a complication among cardiovascular and hemodynamic complications; septic complications; hemorrhagic complications within 7 days after ICU admission
Cardiovascular or hemodynamic complications include ventricular cardiac rhythm disorders, cardiogenic acute pulmonary edema and poorly controlled arterial hypertension [MAP (Mean Arterial Pressure) > 120 mmHg for 4 hours].
Septic complications correspond to sepsis defined by the association of an infection and an increase in SOFA >=2.
Hemorrhagic complications are defined by the number of packed red blood cells (RBCs) used.
Measured: During 7 days after ICU admission.
Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission
Episodes of dysglycemia are defined as hypoglycemia (<4mmol/l) or hyperglycemia (>12mmol/l).
Measured: During 3 days after ICU admission.
ICU and hospital length-of-stay
Total number of days spent in critical care (intensive care, continuous care) and in the initial hospital
Measured: During 28 days from ICU admission
Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters
Known and novel risk factors for AKI in trauma patients will be evaluated using clinical variables (e.g., age, comorbidities, injury severity scores), hemodynamic parameters (e.g., MAP, lactate), and biomarkers of kidney function (e.g., CPK, TIMP-2/IGFBP-7)
Measured: During 7 days from ICU admission
Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria
The incidence of all stages and severe AKI in trauma patients at risk will be assessed based on the KDIGO criteria
Measured: During 3 days after ICU admission
Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria
Acute Kidney Injury episodes will be characterized based on a combination of factors including :
- Time to AKI onset: defined as the time (in hours) from ICU admission to the diagnosis of AKI
- Diagnostic criteria: whether the AKI is diagnosed based on serum creatinine or urine output changes
- Severity: the highest KDIGO stage (1, 2, or 3) reached during the episode
- Duration: transient (<48h) or persistent (≥48h) AKI.
Measured: During 7 days from ICU admission
Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.
The entirety of the nephroprotection bundle-of-care is defined by the combination of at least one practice from each component: medication, hemodynamics, rhabdomyolysis, monitoring, glycemia
Measured: During 3 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.
The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Measured: At 7 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.
The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Measured: At 28 days after ICU admission
Average costs of initial hospital stay for each group
Measured: During 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start9 Jul 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in two phases: Observational phase (4 months): describe the usual management practices and the incidence of AKI in each center. Severe trauma patients (ISS \>15) will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC value will not be disclosed to practitioners. Only patients with NC\>0.3 will be included retrospectively Interventional phase (20 months): aims to evaluate the effectiveness of a nephroprotection bundle-of-care (adaptation of the "KDIGO" protocol). Patients with ISS\>15 will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC result will be returned to the practitioner. If NC \> 0.3, the patient can be included and randomized. Randomization will be stratified by center. In the intervention group, the nephroprotection bundle-of-care will be applied for 3 days following admission to critical care. In the control group, patients will be managed as usual
- Masking
- None (open label)
- Enrolment
- 523 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline MONARD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834633
- Sponsor's protocol ID
- 69HCL21_1435
- Other IDs
- 2022-A01052-41
- Acronym
- NephroTrauma
- Status last verified
- Jul 2026
- First submitted
- 4 Nov 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06834633
- Acronym / sponsor ID
- NephroTrauma / 69HCL21_1435
- Conditions
- Trauma; Complications
- Keywords
- Severe trauma, Acute Kidney Injury, Nephroprotection bundle-of-care, Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 523 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be conducted in two phases: Observational phase (4 months): describe the usual management practices and the incidence of AKI in each center. Severe trauma patients (ISS >15) will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC value will not be disclosed to practitioners. Only patients with NC>0.3 will be included retrospectively Interventional phase (20 months): aims to evaluate the effectiveness of a nephroprotection bundle-of-care (adaptation of the "KDIGO" protocol). Patients with ISS>15 will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC result will be returned to the practitioner. If NC > 0.3, the patient can be included and randomized. Randomization will be stratified by center. In the intervention group, the nephroprotection bundle-of-care will be applied for 3 days following admission to critical care. In the control group, patients will be managed as usual
| Arm | Type | Receives |
|---|---|---|
| Observational group | Other | Other: Standard-of-carePatients in the observational group will be managed according to the unit's standard-of-care, as in the control group, but without investigators knowing the patient's risk of AKI (NC score not known) |
| Control group: Standard-of-care | Other | Other: Standard-of-carePatients at risk of AKI (NC>0.3) randomized in the control group will be managed according to the unit's standard-of-care. |
| Intervention group: nephroprotection bundle-of-care | Experimental | Other: Systematic nephroprotection bundle-of-carePatients at risk of AKI (NC>0.3) randomized in the intervention group will receive the systematic and complete application of a nephroprotection bundle-of-care for three days following ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-of-careManagement according to current ICU practices | Other | Control group: Standard-of-care, Observational group |
| Systematic nephroprotection bundle-of-careThe nephroprotection bundle-of-care includes 5 components: 1. Prevention of drugs' nephrotoxicity 2. Hemodynamic optimization, for 24h 3. Blood glucose control and avoidance of hyperglycemia 4. Early detection of rhabdomyolysis 5. Monitoring of renal function | Other | Intervention group: nephroprotection bundle-of-care |
Primary outcome
Proportion of patients developing an AKI episode within 3 days after ICU admission.
Time frame: During 3 days from ICU admission.
AKI will be defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria, either by a drop in urine output (oliguria < 0.5ml/kg/h for 6h) and/or a rise in serum creatinine (1.5x baseline or increase of 26.5 µmol/l).
14 secondary outcomes
Proportion of patients with AKI within 7 days of ICU admission
Time frame: During 7 days from ICU admission
Proportion of patients with severe AKI within 3 days of ICU admission
Time frame: During 3 days from ICU admission
Proportion of patients with severe AKI within 7 days of ICU admission
Time frame: During 7 days from ICU admission
Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28
Time frame: At 28 days after ICU admission
Proportion of patients with a complication among cardiovascular and hemodynamic complications; septic complications; hemorrhagic complications within 7 days after ICU admission
Time frame: During 7 days after ICU admission.
Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission
Time frame: During 3 days after ICU admission.
ICU and hospital length-of-stay
Time frame: During 28 days from ICU admission
Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters
Time frame: During 7 days from ICU admission
Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria
Time frame: During 3 days after ICU admission
Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria
Time frame: During 7 days from ICU admission
Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.
Time frame: During 3 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.
Time frame: At 7 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.
Time frame: At 28 days after ICU admission
Average costs of initial hospital stay for each group
Time frame: During 28 days after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline MONARD principal investigator
Hospices Civils de Lyon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-of-care and Systematic nephroprotection bundle-of-care in people with Trauma; Complications, run by Hospices Civils de Lyon at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline MONARD (04 72 11 13 27 ext. +33, celine.monard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing an AKI episode within 3 days after ICU admission. (time frame: During 3 days from ICU admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.