on Occurrence of Acurate Kidney Injury During Intensive Care UnitNCT04459975
Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units
An observational study of on Occurrence of Acurate Kidney Injury During Intensive Care Unit and Abnormalities of Urinary Analysis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- on Occurrence of Acurate Kidney Injury During Intensive Care Unit, Abnormalities of Urinary Analysis
- What is being tested?
- Non interventional study
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to Nov 2020
- 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: All patients supported in intensive care units for covid-19 infection
Who may be able to join
- Confirmed COVID-19 infection (by qRT-PCR and/or TDM typical lesion)
- Needing intensive care
Who cannot join
- End Stage Renal Disease patients (with pre-existent dialysis)
- Intensive care support for less than 72h (transfer in conventional unit or death)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive care units attached to the Hospices Civils de Lyon (HCL)
Lyon, 69002
Denis FOUQUE, Professor, +33 472 678 704, denis.fouque@chu-lyon.fr
Maxime EPSI, +33 472 678 704, maxime.espi@chu-lyon.fr
About this study
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm".
The aims of this study are:
- To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
- To identify specific risk factors for AKI
- To explore pathophysiologic mechanism of AKI during COVID-19 infection
- Conditions
- on Occurrence of Acurate Kidney Injury During Intensive Care Unit, Abnormalities of Urinary Analysis
- Being tested
- Non interventional study
- Keywords
- Acurate Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient.
Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis
| Study group | Role | What they receive |
|---|---|---|
| AKI (-) | patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine > 1,5x baseline according with KDIGO guidelines) | |
| AKI (+) | patient treated in ICU for COVID-19 infection and with occurrence of AKI among which:
• Severe AKI patients (define as creatinine > 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death). Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection
AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Apr 2020
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for on Occurrence of Acurate Kidney Injury During Intensive Care UnitStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459975
- Sponsor's protocol ID
- CoV-AKI_2020
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2020
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units
- ClinicalTrials.gov ID
- NCT04459975
- Acronym / sponsor ID
- CoV-AKI_2020
- Conditions
- on Occurrence of Acurate Kidney Injury During Intensive Care Unit, Abnormalities of Urinary Analysis
- Keywords
- Acurate Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 7 Jul 2020 (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.
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm".
The aims of this study are:
- To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
- To identify specific risk factors for AKI
- To explore pathophysiologic mechanism of AKI during COVID-19 infection
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI (-) | – | –patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine > 1,5x baseline according with KDIGO guidelines) |
| AKI (+) | – | Other: Non interventional studypatient treated in ICU for COVID-19 infection and with occurrence of AKI among which: • Severe AKI patients (define as creatinine > 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients supported in intensive care units for covid-19 infection
Key inclusion criteria (2 listed)
- Confirmed COVID-19 infection (by qRT-PCR and/or TDM typical lesion)
- Needing intensive care
Key exclusion criteria (2 listed)
- End Stage Renal Disease patients (with pre-existent dialysis)
- Intensive care support for less than 72h (transfer in conventional unit or death)
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 |
|---|---|---|
| Non interventional studyComorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient. Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis | Other | AKI (+) |
Primary outcome
Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection
Time frame: 7 months
AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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.
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 on Occurrence of Acurate Kidney Injury During Intensive Care Unit and Abnormalities of Urinary Analysis, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denis FOUQUE, Professor (+33 472 678 704, denis.fouque@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection (time frame: 7 months). 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 7 Jul 2020.