Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06834633

Nephroprotection in Severe Trauma Patients With Kidney Stress

Led by Hospices Civils de Lyon · Updated on 2025-07-11

523

Participants Needed

6

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Nephroprotection in Severe Trauma Patients With Kidney Stress

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient (18 years or older)
  • Severe trauma with Injury Severity Score (ISS) above 15 admitted to a trauma center
  • Time between trauma and trauma center admission less than 6 hours
  • Presence of an indwelling urinary catheter
  • High risk of AKI defined by a Nephrocheck score above 0.3 within 12 hours of ICU admission
  • Affiliated with a social security or similar scheme
  • Signed consent by patient, close relative, or investigator in emergencies
Not Eligible

You will not qualify if you...

  • Adult under legal protection (guardianship or curatorship)
  • Persons deprived of liberty by judicial or administrative decision
  • Participation in other interventional research with ongoing exclusion period
  • Pregnant or breastfeeding women
  • End-stage or severe chronic kidney failure with GFR less than 30 ml/min/1.73m2 or on chronic dialysis
  • Anuric patients
  • Severe heart failure with left ventricular ejection fraction below 25%
  • Moribund patients on admission expected to stay less than 24 hours
  • Patients with AKI prior to or within 12 hours of ICU admission before randomization

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation

Clermont-Ferrand, France, 63100

Not Yet Recruiting

2

Centre hospitaler Annecy Genevois, Service de réanimation

Épagny, France, 74370

Not Yet Recruiting

3

Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation

La Tronche, France, 38700

Not Yet Recruiting

4

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

Lyon, France, 69003

Actively Recruiting

5

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

Pierre-Bénite, France, 69310

Actively Recruiting

6

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

Saint-Etienne, France, 42000

Not Yet Recruiting

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Research Team

C

Céline MONARD

CONTACT

K

Karine POYAU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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