Acute Kidney Injury Clinical Trial
— NEPHROTRAUMAOfficial title:
Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients
| NCT number | NCT03877978 |
| Other study ID # | 69HCL18_0903 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 16, 2019 |
| Est. completion date | December 2, 2021 |
| Verified date | May 2022 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 196 |
| Est. completion date | December 2, 2021 |
| Est. primary completion date | December 2, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Edouard Herriot | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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