Acute Kidney Attack in Severe Traumatized Patients | NCT03877978

Studies
Acute Kidney Attack in Severe Traumatized Patients

NCT03877978

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

May 20, 2022Actual

Enrollment

196Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Nephrocheck test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2019Actual

Primary Completion Date

Dec 2, 2021Actual

Completion Date

Dec 2, 2021Actual

First Submitted Date

Mar 14, 2019

First Submission Date that Met QC Criteria

Mar 14, 2019

First Posted Date

Mar 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2022

Last Update Posted Date

May 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

196Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nephrocheck test	Biological	Nephrocheck® measurement on urine sample at different timepoints.	Severe traumatized patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Edouard Herriot		Lyon		69003	France

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided