Acute Kidney Attack in Severe Traumatized Patients

NCT03877978 | Completed

• 1 other identifier: 69HCL18_0903
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of patients with Nephrocheck score > 0,3

  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

Study Arms (1)

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

Interventions

Nephrocheck test BIOLOGICAL

Nephrocheck® measurement on urine sample at different timepoints.

Severe traumatized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Violette Zorio

  Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: May 16, 2019
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

FR (1)