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Acute Kidney Attack in Severe Traumatized Patients (NEPHROTRAUMA)

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ClinicalTrials.gov Identifier: NCT03877978
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date March 14, 2019
First Posted Date March 18, 2019
Last Update Posted Date March 18, 2019
Estimated Study Start Date April 15, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Attack in Severe Traumatized Patients
Official Title Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples
Sampling Method Non-Probability Sample
Study Population Severe traumatized patients with an ISS ≥ 15 admitted to the trauma center of Edouard Herriot Hospital
Condition Acute Kidney Injury
Intervention Biological: Nephrocheck test
Nephrocheck® measurement on urine sample at different timepoints.
Study Groups/Cohorts Severe traumatized patients
Severe traumatized patients with an Index Severity Score (ISS) ≥ 15 admitted to the trauma center of Edouard Herriot Hospital.
Intervention: Biological: Nephrocheck test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 14, 2019)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Violette Zorio 00 33 04 72 11 11 90 violette.zorio@chu-lyon.fr
Contact: Julien Textoris 00 33 04 72 14 03 19 julien.textoris@chu-lyon.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03877978
Other Study ID Numbers 69HCL18_0903
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Violette Zorio Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE
PRS Account Hospices Civils de Lyon
Verification Date February 2019