Nephroprotection in Severe Trauma Patients With Kidney Stress

NCT06834633 | Recruiting

• 2 other identifiers: 69HCL21_14352022-A01052-41
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Trauma; Complications

Keywords

Severe trauma; Acute Kidney Injury; Nephroprotection bundle-of-care; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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).

  During 3 days from ICU admission.

Secondary Outcomes (14)

• Proportion of patients with AKI within 7 days of ICU admission

  During 7 days from ICU admission

• Proportion of patients with severe AKI within 3 days of ICU admission

  During 3 days from ICU admission

• Proportion of patients with severe AKI within 7 days of ICU admission

  During 7 days from ICU admission

• Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28

  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

  During 7 days after ICU admission.

Study Arms (3)

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)

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.

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.

Other: Systematic nephroprotection bundle-of-care

Interventions

Standard-of-care OTHER

Management according to current ICU practices

Control group: Standard-of-care; Observational group

Systematic nephroprotection bundle-of-care OTHER

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

Intervention group: nephroprotection bundle-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adult under legal protection (guardianship, curators)
• Persons deprived of their liberty by judicial or administrative decision
• 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).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (6)

Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation

Clermont-Ferrand, 63100, France

NOT YET RECRUITING

Centre hospitaler Annecy Genevois, Service de réanimation

Épagny, 74370, France

NOT YET RECRUITING

Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation

La Tronche, 38700, France

NOT YET RECRUITING

Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation

Lyon, 69003, France

RECRUITING

Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation

Pierre-Bénite, 69310, France

RECRUITING

Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation

Saint-Etienne, 42000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Céline MONARD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline MONARD

CONTACT

04 72 11 13 27; celine.monard@chu-lyon.fr

Karine POYAU

CONTACT

04 72 11 53 81; karine.poyau@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: February 19, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)