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Acute Kidney Attack in Severe Traumatized Patients (NEPHROTRAUMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03877978
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test >0.3

Condition or disease Intervention/treatment
Acute Kidney Injury Biological: Nephrocheck test

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Group/Cohort Intervention/treatment
Severe traumatized patients
Severe traumatized patients with an Index Severity Score (ISS) ≥ 15 admitted to the trauma center of Edouard Herriot Hospital.
Biological: Nephrocheck test
Nephrocheck® measurement on urine sample at different timepoints.

Primary Outcome Measures :
  1. Incidence of patients with Nephrocheck score > 0,3 [ Time Frame: Up to 24 hours after trauma ]
    Incidence of severe traumatized patient at risk of AKI as defined by Nephrocheck test score > 0,3 within the first 24 hours after admission

Biospecimen Retention:   Samples Without DNA
Urine samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe traumatized patients with an ISS ≥ 15 admitted to the trauma center of Edouard Herriot Hospital

Inclusion Criteria:

  • age >18 years
  • trauma patients with ISS ≥15
  • patient admitted to the resuscitation bay of Edouard Herriot Hospital

Exclusion Criteria:

  • anuric patient
  • opposition of the patient (or a trusted person) to participate
  • pregnant or lactating woman
  • age <18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03877978

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Contact: Violette Zorio 00 33 04 72 11 11 90
Contact: Julien Textoris 00 33 04 72 14 03 19

Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Violette Zorio Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE

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Responsible Party: Hospices Civils de Lyon Identifier: NCT03877978     History of Changes
Other Study ID Numbers: 69HCL18_0903
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases