Acute Kidney InjuryNEPHROTRAUMANCT03877978
Acute Kidney Attack in Severe Traumatized Patients
An observational study of Acute Kidney Injury, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Nephrocheck test
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2019to 2 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe traumatized patients with an ISS ≥ 15 admitted to the trauma center of Edouard Herriot Hospital
Who may be able to join
- age >18 years
- trauma patients with ISS ≥15
- patient admitted to the resuscitation bay of Edouard Herriot Hospital
Who cannot join
- anuric patient
- opposition of the patient (or a trusted person) to participate
- pregnant or lactating woman
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Acute Kidney Injury
- Being tested
- Nephrocheck test
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephrocheck testBiological
Nephrocheck® measurement on urine sample at different timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Severe traumatized patients | Severe traumatized patients with an Index Severity Score (ISS) ≥ 15 admitted to the trauma center of Edouard Herriot Hospital. Receives: Biological: Nephrocheck test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 hours after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start16 May 2019
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Violette Zorio, Principal investigator, Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877978
- Sponsor's protocol ID
- 69HCL18_0903
- Acronym
- NEPHROTRAUMA
- Status last verified
- May 2022
- First submitted
- 14 Mar 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients
- ClinicalTrials.gov ID
- NCT03877978
- Acronym / sponsor ID
- NEPHROTRAUMA / 69HCL18_0903
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe traumatized patients | – | Biological: Nephrocheck testSevere traumatized patients with an Index Severity Score (ISS) ≥ 15 admitted to the trauma center of Edouard Herriot Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe traumatized patients with an ISS ≥ 15 admitted to the trauma center of Edouard Herriot Hospital
Key inclusion criteria (3 listed)
- age >18 years
- trauma patients with ISS ≥15
- patient admitted to the resuscitation bay of Edouard Herriot Hospital
Key exclusion criteria (4 listed)
- anuric patient
- opposition of the patient (or a trusted person) to participate
- pregnant or lactating woman
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nephrocheck testNephrocheck® measurement on urine sample at different timepoints. | Biological | Severe traumatized patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Violette Zorio principal investigator
Intensive Care Unit, Pavillon H - Réanimation chirurgicale. Edouard Herriot hospital 5 place d'Arsonval - 69003 Lyon FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients with Nephrocheck score > 0,3 (time frame: Up to 24 hours after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.