Nephroprotection in Severe Trauma Patients With Kidney Stress

Not Applicable

Not yet recruiting

• Conditions: Trauma; Complications

• Registration Number: NCT06834633
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-03
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 523

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing an AKI episode within 3 days after ICU admission.	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with AKI within 7 days of ICU admission	During 7 days from 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).
Proportion of patients with severe AKI within 3 days of ICU admission	During 3 days from ICU admission	Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Proportion of patients with severe AKI within 7 days of ICU admission	During 7 days from ICU admission	Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28	At 28 days after ICU admission	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.
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.	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.
Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission	During 3 days after ICU admission.	Episodes of dysglycemia are defined as hypoglycemia (\<4mmol/l) or hyperglycemia (\>12mmol/l).
ICU and hospital length-of-stay	During 28 days from ICU admission	Total number of days spent in critical care (intensive care, continuous care) and in the initial hospital
Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters	During 7 days from ICU admission	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)
Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria	During 3 days after ICU admission	The incidence of all stages and severe AKI in trauma patients at risk will be assessed based on the KDIGO criteria
Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria	During 7 days from ICU admission	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.
Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.	During 3 days after ICU admission	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
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.	At 7 days after ICU admission	The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.	At 28 days after ICU admission	The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Average costs of initial hospital stay for each group	During 28 days after ICU admission

Trial Locations

Locations (6)

Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation; 🇫🇷 Clermont-Ferrand, 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-Étienne, France

Centre hospitaler Annecy Genevois, Service de réanimation; 🇫🇷 Épagny, France