Nephroprotection in Severe Trauma Patients With Kidney Stress
NCT ID: NCT06834633
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
523 participants
INTERVENTIONAL
2025-07-09
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
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Observational group
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)
Standard-of-care
Management according to current ICU practices
Control group: Standard-of-care
Patients at risk of AKI (NC\>0.3) randomized in the control group will be managed according to the unit's standard-of-care.
Standard-of-care
Management according to current ICU practices
Intervention group: nephroprotection bundle-of-care
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.
Systematic nephroprotection bundle-of-care
The 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
Interventions
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Standard-of-care
Management according to current ICU practices
Systematic nephroprotection bundle-of-care
The 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Céline MONARD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
Clermont-Ferrand, , France
Centre hospitaler Annecy Genevois, Service de réanimation
Épagny, , France
Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
La Tronche, , France
Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
Lyon, , France
Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
Pierre-Bénite, , France
Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
Saint-Etienne, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01052-41
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL21_1435
Identifier Type: -
Identifier Source: org_study_id
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