연구제목

Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial

연구요약

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.

연구의뢰자

Hospices Civils de Lyon

연구모집현황

NOT_YET_RECRUITING

임상시험의 목적

TREATMENT

ClinicalTrials.gov 등록번호

NCT06834633

추가 연구 번호

최신갱신일

2025-06-11

연구종료일

2027-08

연구 버전 기록

실시기관명

facility: Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
city: Clermont-Ferrand
zip: 63100
country: France
contacts: [{name=Benjamin RIEU, MD, role=CONTACT, phone=04 73 75 05 06, phoneExt=+33, email=brieu@chu-clermontferrand.fr}, {name=Benjamin RIEU, MD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.77966, lon=3.08628}

facility: Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
city: La Tronche
zip: 38700
country: France
contacts: [{name=Thibaut TROUVE-BUISSON, MD, role=CONTACT, phone=04 76 76 52 95, phoneExt=+33, email=ttrouvebuisson@chu-grenoble.fr}, {name=Thibaut TROUVE-BUISSON, MD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.20429, lon=5.73645}

facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
city: Lyon
zip: 69003
country: France
contacts: [{name=Céline MONARD, MD, role=CONTACT, phone=04 72 11 13 27, phoneExt=+33, email=celine.monard@chu-lyon.fr}, {name=Céline MONARD, MD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.74848, lon=4.84669}

facility: Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
city: Pierre-Bénite
zip: 69310
country: France
contacts: [{name=Jean-Stéphane DAVID, MD, PhD, role=CONTACT, phone=04 78 86 57 56, phoneExt=+33, email=jean-stephane.david@chu-lyon.fr}, {name=Jean-Stéphane DAVID, MD, PhD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.7009, lon=4.82511}

facility: Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
city: Saint-Étienne
zip: 42000
country: France
contacts: [{name=Jérôme MOREL, MD, PhD, role=CONTACT, phone=04 77 82 83 29, phoneExt=+33, email=jerome.morel@chu-st-etienne.fr}, {name=Jérôme MOREL, MD, PhD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.43389, lon=4.39}

facility: Centre hospitaler Annecy Genevois, Service de réanimation
city: Épagny
zip: 74370
country: France
contacts: [{name=Albrice LEVRAT, MD, role=CONTACT, phone=04 50 63 60 30, phoneExt=+33, email=alevrat@ch-annecygenevois.fr}, {name=Albrice LEVRAT, MD, role=PRINCIPAL_INVESTIGATOR}]
geoPoint: {lat=45.93805, lon=6.09095}

연구대상 상태/질환

Trauma; Complications

대상질환

id: M28998
name: Acute Kidney Injury
relevance: LOW

id: M17685
name: Wounds and Injuries
asFound: Trauma
relevance: HIGH

id: T170
name: Acute Graft Versus Host Disease
relevance: LOW

제품명(코드명)

활성대조약 여부

대조약 여부

위약 여부

대조약

-

중재/치료

type: OTHER
name: Standard-of-care
description: Management according to current ICU practices
armGroupLabels: [Control group: Standard-of-care, Observational group]

type: OTHER
name: Systematic nephroprotection bundle-of-care
description: 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
armGroupLabels: [Intervention group: nephroprotection bundle-of-care]

중재 방법

연구종류

INTERVENTIONAL

임상시험단계

NA

배정

RANDOMIZED

중재모형

PARALLEL

눈가림대상자

중재군명

중재군 유형

label: Observational group
type: OTHER
description: 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)
interventionNames: [Other: Standard-of-care]

label: Control group: Standard-of-care
type: OTHER
description: Patients at risk of AKI (NC\>0.3) randomized in the control group will be managed according to the unit's standard-of-care.
interventionNames: [Other: Standard-of-care]

label: Intervention group: nephroprotection bundle-of-care
type: EXPERIMENTAL
description: 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.
interventionNames: [Other: Systematic nephroprotection bundle-of-care]

중재군 수

0

중재군 별 설명 및 등록 환자수

중재군 목표대상자 수

0

기관소재지

실시기관 전화번호

연구참여기관

국가

환자모집국가

최초 연구대상자 등록일

2025-06

상세내용

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

대상자 선정 및 제외기준

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).

참여 가능한 연령 하한

18 Years

참여 가능한 연령 상한

참여 가능한 표준 연령

ADULT

OLDER_ADULT

대상자 포함기준 성별

ALL

건강인 참여 여부

NO

실제 대상자수

523

기존 목표대상자 수(실제)

0

최종 연구대상자 수

0

최종 시험대상자 선정일

시험대상자 > 분석대상군

시험대상자 > 인구학적 정보

주요결과변수

measure: Proportion of patients developing an AKI episode within 3 days after ICU admission.
description: 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).
timeFrame: During 3 days from ICU admission.

보조결과변수

measure: Proportion of patients with AKI within 7 days of ICU admission
description: 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).
timeFrame: During 7 days from ICU admission

measure: Proportion of patients with severe AKI within 3 days of ICU admission
description: Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
timeFrame: During 3 days from ICU admission

measure: Proportion of patients with severe AKI within 7 days of ICU admission
description: Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
timeFrame: During 7 days from ICU admission

measure: Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28
description: 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.
timeFrame: At 28 days after ICU admission

measure: Proportion of patients with a complication among cardiovascular and hemodynamic complications; septic complications; hemorrhagic complications within 7 days after ICU admission
description: 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.
timeFrame: During 7 days after ICU admission.

measure: Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission
description: Episodes of dysglycemia are defined as hypoglycemia (\<4mmol/l) or hyperglycemia (\>12mmol/l).
timeFrame: During 3 days after ICU admission.

measure: ICU and hospital length-of-stay
description: Total number of days spent in critical care (intensive care, continuous care) and in the initial hospital
timeFrame: During 28 days from ICU admission

measure: Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters
description: 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)
timeFrame: During 7 days from ICU admission

measure: Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria
description: The incidence of all stages and severe AKI in trauma patients at risk will be assessed based on the KDIGO criteria
timeFrame: During 3 days after ICU admission

measure: Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria
description: 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.
timeFrame: During 7 days from ICU admission

measure: Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.
description: 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
timeFrame: During 3 days after ICU admission

measure: Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.
description: The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
timeFrame: At 7 days after ICU admission

measure: Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.
description: The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
timeFrame: At 28 days after ICU admission

measure: Average costs of initial hospital stay for each group
timeFrame: During 28 days after ICU admission

주요 평가 > 1차 평가변수 결과

최종 주평가변수 수집 완료일

2027-08

임상시험결과요약

연구책임자 전화번호

연구책임자 주소

연구실무담당자 성명

연구실무담당자 직위

연구실무담당자 전화번호

name: Céline MONARD
role: CONTACT
phone: 04 72 11 13 27
phoneExt: +33
email: celine.monard@chu-lyon.fr

name: Karine POYAU
role: CONTACT
phone: 04 72 11 53 81
phoneExt: +33
email: karine.poyau@chu-lyon.fr

연구실무담당자 기관명