Acute Kidney Attack in Severe Traumatized Patients (NEPHROTRAUMA)

May 19, 2022 updated by: Hospices Civils de Lyon

Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hopital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe traumatized patients with an ISS ≥ 15 admitted to the trauma center of Edouard Herriot Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 hours after trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Violette Zorio, Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2019

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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